MastectomyNCT05368519
Brijjit® for Wound Closure in Gender Affirming Mastectomies
A study testing Brijjit® in people with Mastectomy, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will evaluate the use of Brijjit® for wound closure in individuals undergoing bilateral double incision gender affirming mastectomies with a single surgeon (Rachel Bluebond-Langner, MD). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mastectomy
- What is being tested?
- Brijjit®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient self-identifies as Transgender or Gender Expansive
- Patient will undergo primary bilateral double incision mastectomy at NYULH
- All clinical criteria to be eligible for primary mastectomy must be met
- Ability to care for donor site and adhere to wound therapy (either solo or with care-giver assistance)
- Willingness to return for scheduled follow-up visits through 1 year post-operatively
- 18 years of age or older
- English Speaking
Who cannot join
- Individuals with previously diagnosed allergies or a history of adverse effects related to adhesives / adhesive tapes
- Individuals with a history of the following prescription medication use in the last year: Accutane, Systemic glucocorticoids and/or Local glucocorticoids or immunosuppressants (i.e. topical tacrolimus, topical clindamycin etc.) at the intervention site
- Individuals with a history of significant scarring or adverse scarring (hypertrophic scars or keloid scars)
- Individuals with pre-existing scars at the GAM wound closure site
- Individuals with a disorder known to negatively affect wound healing (i.e. autoimmune disease, connective tissue disease)
- Individuals with malnutrition
Show all 14Show fewer
- Individuals with a BMI >30 kg/m2
- Individuals with a history of radiation therapy
- Active smokers or smokeless nicotine use
- History of Previous Mastectomy
- Patient is actively immunosuppressed i.e. AIDS (HIV+ acceptable), or Systemic immunosuppressants
- Patients unable to attend post-operative follow-ups in person
- Patients with a considerable history of medical non-compliance
- Patient will receive GAM not including double incisions (i.e. periareolar)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center Study of Brijjit® - A Force Modulating Tissue Bridge For Skin Closure in Gender-Affirming Mastectomies
This study will evaluate the use of Brijjit® for wound closure in individuals undergoing bilateral double incision gender affirming mastectomies with a single surgeon (Rachel Bluebond-Langner, MD). The study will be a randomized prospective interventional study utilizing internal controls (one side of chest receives intervention, other serves as control). Primary endpoints will include scar appearance/quality and wound complications
Read the detailed description
The hypothesis of this study is that the use of Brijjit® FMTB will result in improved scar outcomes as measured by both patient and treating physician as compared to traditional suture based wound closure methods. As mentioned, at present there is no standard of care for wound closure following double incision GAM, therefore an internal control approach will be taken with patients serving as their own controls. This will be achieved by having one side of the chest receive the of Brijjit® FMTB (intervention) in addition to suture closure of the skin, while the other side will be closed with traditional methods, a combination of sutures and steri-stripsTM (control).
- Conditions
- Mastectomy
- Being tested
- Brijjit®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brijjit®Device
Also called Brijjit® BP100-6
Brijjit® is a non-invasive device which serves as a force modulating tissues bridges (FMTB) to aid in wound healing. This device used in would closure and serves to modify the mechanical forces on a wound which are implicated in adverse outcomes including scar formation and complications like wound dehiscence. Brijjit® is a flexible device which attaches via adhesive to the tissue on either side of the wound, approximates the tissue and off-loads forces.
| Study group | Role | What they receive |
|---|---|---|
| Right chest with Brijjit® FMTB | Experimental | Patients will be assigned to have their right chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control. Receives: Device: Brijjit® |
| Left chest with Brijjit® FMTB | Experimental | Patients will be assigned to have their left chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control. Receives: Device: Brijjit® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: screening/baseline visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: week 2 visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: week 4 visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: week 6 visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: week 8 visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: 3-month post-surgery visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: 6-months post-surgery visit
Subjective scar evaluation by patient outcomes using POSAS
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: 12-months post-surgery visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: screening/baseline visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: week 2 visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: week 4 visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: week 6 visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: week 8 visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: 3-month post-surgery visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: 6-months post-surgery visit
Subjective scar evaluation by surgeon outcomes using POSAS
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Measured: 12-months post-surgery visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Measured: screening/baseline visir
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Measured: week 2 visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Measured: week 4 visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Measured: week 6 visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Measured: week 8 visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Measured: 3-month post-surgery visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Measured: 6-months post-surgery visit
Photographic assessment for objective scar evaluation
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Measured: 12-months post-surgery visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Measured: screening/baseline visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Measured: week 2 visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Measured: week 4 visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Measured: week 6 visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Measured: week 8 visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Measured: 3-month post-surgery visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Measured: 6-months post-surgery visit
Colorimetry of Scar
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Measured: 12-months post-surgery visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion19 Apr 2024 (estimated)
- Study completion19 Apr 2024 (estimated)
Why it stopped: Patients were not interested in participating in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Bluebond-Langner, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368519
- Sponsor's protocol ID
- 22-00304
- Status last verified
- Aug 2022
- First submitted
- 3 May 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Study of Brijjit® - A Force Modulating Tissue Bridge For Skin Closure in Gender-Affirming Mastectomies
- ClinicalTrials.gov ID
- NCT05368519
- Acronym / sponsor ID
- 22-00304
- Conditions
- Mastectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients were not interested in participating in the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 19 Apr 2024 (estimated)
- Study completion
- 19 Apr 2024 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the use of Brijjit® for wound closure in individuals undergoing bilateral double incision gender affirming mastectomies with a single surgeon (Rachel Bluebond-Langner, MD). The study will be a randomized prospective interventional study utilizing internal controls (one side of chest receives intervention, other serves as control). Primary endpoints will include scar appearance/quality and wound complications
Detailed description
The hypothesis of this study is that the use of Brijjit® FMTB will result in improved scar outcomes as measured by both patient and treating physician as compared to traditional suture based wound closure methods. As mentioned, at present there is no standard of care for wound closure following double incision GAM, therefore an internal control approach will be taken with patients serving as their own controls. This will be achieved by having one side of the chest receive the of Brijjit® FMTB (intervention) in addition to suture closure of the skin, while the other side will be closed with traditional methods, a combination of sutures and steri-stripsTM (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right chest with Brijjit® FMTB | Experimental | Device: Brijjit®Patients will be assigned to have their right chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control. |
| Left chest with Brijjit® FMTB | Experimental | Device: Brijjit®Patients will be assigned to have their left chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient self-identifies as Transgender or Gender Expansive
- Patient will undergo primary bilateral double incision mastectomy at NYULH
- All clinical criteria to be eligible for primary mastectomy must be met
- Ability to care for donor site and adhere to wound therapy (either solo or with care-giver assistance)
- Willingness to return for scheduled follow-up visits through 1 year post-operatively
Key exclusion criteria (14 listed)
- Individuals with previously diagnosed allergies or a history of adverse effects related to adhesives / adhesive tapes
- Individuals with a history of the following prescription medication use in the last year: Accutane, Systemic glucocorticoids and/or Local glucocorticoids or immunosuppressants (i.e. topical tacrolimus, topical clindamycin etc.) at the intervention site
- Individuals with a history of significant scarring or adverse scarring (hypertrophic scars or keloid scars)
- Individuals with pre-existing scars at the GAM wound closure site
- Individuals with a disorder known to negatively affect wound healing (i.e. autoimmune disease, connective tissue disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brijjit®Also: Brijjit® BP100-6Brijjit® is a non-invasive device which serves as a force modulating tissues bridges (FMTB) to aid in wound healing. This device used in would closure and serves to modify the mechanical forces on a wound which are implicated in adverse outcomes including scar formation and complications like wound dehiscence. Brijjit® is a flexible device which attaches via adhesive to the tissue on either side of the wound, approximates the tissue and off-loads forces. | Device | Left chest with Brijjit® FMTB, Right chest with Brijjit® FMTB |
Primary outcome
Subjective scar evaluation by patient outcomes using POSAS
Time frame: screening/baseline visit
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by patient outcomes using POSAS
Time frame: week 2 visit
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by patient outcomes using POSAS
Time frame: week 4 visit
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by patient outcomes using POSAS
Time frame: week 6 visit
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by patient outcomes using POSAS
Time frame: week 8 visit
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by patient outcomes using POSAS
Time frame: 3-month post-surgery visit
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by patient outcomes using POSAS
Time frame: 6-months post-surgery visit
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by patient outcomes using POSAS
Time frame: 12-months post-surgery visit
Patient and Observer assessment scale (POSAS) will be used to visually assess their scar appearance and complete the 10-point scale. The patient scale will include questions regarding pain, itch, thickness, color, stiffness, irregularity, and overall opinion. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by surgeon outcomes using POSAS
Time frame: screening/baseline visit
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by surgeon outcomes using POSAS
Time frame: week 2 visit
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by surgeon outcomes using POSAS
Time frame: week 4 visit
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by surgeon outcomes using POSAS
Time frame: week 6 visit
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by surgeon outcomes using POSAS
Time frame: week 8 visit
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by surgeon outcomes using POSAS
Time frame: 3-month post-surgery visit
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by surgeon outcomes using POSAS
Time frame: 6-months post-surgery visit
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Subjective scar evaluation by surgeon outcomes using POSAS
Time frame: 12-months post-surgery visit
Clinician will visually assess the scar appearance during the visit and complete the 10-point scale. The observer scale will include items with subcategories related to vascularity, pigmentation, relief/texture, thickness, pliability, surface area and overall opinion.Scores are tabulated out of 70. Each item on both scales has a score of 1 to 10. The lowest score is 1 and corresponds to the normal skin situation. The total score of both scales can be calculated simply by adding the scores of each of the six items. The total score will range from 6 to 60.
Photographic assessment for objective scar evaluation
Time frame: screening/baseline visir
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Photographic assessment for objective scar evaluation
Time frame: week 2 visit
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Photographic assessment for objective scar evaluation
Time frame: week 4 visit
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Photographic assessment for objective scar evaluation
Time frame: week 6 visit
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Photographic assessment for objective scar evaluation
Time frame: week 8 visit
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Photographic assessment for objective scar evaluation
Time frame: 3-month post-surgery visit
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Photographic assessment for objective scar evaluation
Time frame: 6-months post-surgery visit
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Photographic assessment for objective scar evaluation
Time frame: 12-months post-surgery visit
Standard and close-up photography (part of standard of care) will be utilized for evaluation of the appearance surgical scars. These photographs will be taken utilizing the Nikon D7200 at screening/baseline, week 2, week 4, week 6, week 8, 3-month post-surgery, 6-months post-surgery and 12-months post-surgery. There will be no statistical analyses employed on the photographs
Colorimetry of Scar
Time frame: screening/baseline visit
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Colorimetry of Scar
Time frame: week 2 visit
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Colorimetry of Scar
Time frame: week 4 visit
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Colorimetry of Scar
Time frame: week 6 visit
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Colorimetry of Scar
Time frame: week 8 visit
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Colorimetry of Scar
Time frame: 3-month post-surgery visit
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Colorimetry of Scar
Time frame: 6-months post-surgery visit
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Colorimetry of Scar
Time frame: 12-months post-surgery visit
The Pantone SkinTone Guide is a handheld tool consisting of 110 color swatches that realistically mimic human skin tones, with stepwise variations in lightness and undertone. The guide was specifically formulated to be the closest physical representation of skin colors and is the only internationally available color standard to accurately match skin tones. Each SkinTone number is comprised of a four-digit alphanumeric number; the first two numbers reflect the hue or undertone of the skin while the second two represent the tone or lightness and darkness of the skin. This tool will be utilized to establish a clinically acceptable objective assessment for assessing the coloring of patients' scars.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Bluebond-Langner principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brijjit® in people with Mastectomy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective scar evaluation by patient outcomes using POSAS (time frame: screening/baseline visit). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.