Surgical IncisionNCT05028816
Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
A study testing Side 1: Final layer closure with force modulating tissue bridges (FMTB), Side 1: Final layer dermal closure with poliglecaprone 25 suture and Side 2: Final layer closure with force modulating tissue bridges (FMTB) in people with Surgical Incision, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Incision
- What is being tested?
- Side 1: Final layer closure with force modulating tissue bridges (FMTB), Side 1: Final layer dermal closure with poliglecaprone 25 suture and Side 2: Final layer closure with force modulating tissue bridges (FMTB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult females 18-65 years of age
- Planned procedure is bilateral breast reduction with modified Wise (anchor, inverted "T") scar pattern.
- Ability to adhere wound therapy after surgery for 8 weeks or have a willing family member/partner to assist with wound therapy care.
- Willing to follow wound care therapy as instructed by study staff.
- Willing to return for follow up visits and undergo study evaluations.
Who cannot join
- Individuals diagnosed with known allergy to general adhesives/adhesive tape
- Individuals with a history of using the following prescription medications:
- Accutane within the past year;
- Systemic steroid use within the past year
- Individuals who have significant scarring on the test site/area(s)
- Individuals with malnutrition
Show all 12Show fewer
- Individuals who have a body mass index >35
- Individual who have a history of radiation therapy
- Individual who have a history of breast cancer
- Active smokers
- Individuals with a disorder known to negatively affect wound healing (e.g. autoimmune disease, connective tissue disease
- Individual who have an observable pre-operative or intra-operative breast asymmetry that, in the investigators opinion, would interfere with the evaluation of the efficacy of the wound therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center- Outpatient Building
Dallas, Texas, 75390
About this study
This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern
Read the detailed description
This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern. Subjects will be randomized to the method of closure and wound support of the symmetrical vertical breast incisions. On the intervention side subjects will have FMTBs applied for final layer closure of the vertical breast incision and will continue with repeat application every two weeks for ongoing wound support for a total of 8 weeks of therapy. On the control side standard suture closure and wound dressings will be utilized. Patients will be evaluated at two-week intervals up until 8 weeks post-operative, then will have 3 additional follow up visits at 3-months, 6-months and 12-months post-operatively. The effects of the therapy will be analyzed during the follow up visits through photography, skin assessments and POSAS (Patient and Observer Scar Assessment Scale) results. A subgroup of 10 patients will also undergo biopsies of the area of interest at five time points throughout the study. Primary study outcomes include POSAS results and photographic assessment while secondary outcomes include scar volume/surface area, gene regulation and genetic analysis obtained via biopsies, collagen volume, skin assessments, colorimetry and time of length of adherence of the device.
- Conditions
- Surgical Incision
- Being tested
- Side 1: Final layer closure with force modulating tissue bridges (FMTB), Side 1: Final layer dermal closure with poliglecaprone 25 suture, Side 2: Final layer closure with force modulating tissue bridges (FMTB), Side 2: Final layer dermal closure with poliglecaprone 25 suture
- Keywords
- Wound Healing
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side 1: Final layer closure with force modulating tissue bridges (FMTB)Device
Also called Brijjit
Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.
Side 1: Final layer dermal closure with poliglecaprone 25 sutureOther
Current method of wound closure
Side 2: Final layer closure with force modulating tissue bridges (FMTB)Device
Also called Brijjit
Brijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance.
Side 2: Final layer dermal closure with poliglecaprone 25 sutureOther
Current method of wound closure
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Side 1: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ)
Side 2: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA) Receives: Other: Side 1: Final layer dermal closure with poliglecaprone 25 suture; Device: Side 2: Final layer closure with force modulating tissue bridges (FMTB) |
| Group 2 | Other | Side 1: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA)
Side 2: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ) Receives: Device: Side 1: Final layer closure with force modulating tissue bridges (FMTB); Other: Side 2: Final layer dermal closure with poliglecaprone 25 suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.
Scoring:
Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where:
1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient.
The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Measured: 12 Months
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.
Scoring:
Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where:
1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient.
The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Measured: 6 Months
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.
Scoring:
Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where:
1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient.
The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Measured: 3 Months
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.
Scoring:
Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where:
1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient.
The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Measured: 3 Months
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.
Scoring:
Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where:
1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient.
The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Measured: 12 Months
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective.
Scoring:
Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where:
1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient.
The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Measured: 6 Months
Secondary outcomes (14)
Scar Area Assessment
eKare will be used to asses scars progression over an 8-week period.
The data is an average at each timepoints.
Measured: Week 2, Week 4, Week 6 and Week 8
Gene Regulation- Elastin
Assessment of mechanical properties of regenerated skin
Fold change= sample/average of the baseline
Measured: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Gene Analysis- Macrophage
Biopsy will be obtained to assess progression of tissue Fold change= sample/average of the baseline
Measured: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Histology Collagen 3
Biopsy will be obtained to assess early wound healing and ECM formation during scaffold integration Fold change= sample/average of the baseline
Measured: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Change in Mechanical Properties of Human Tissue
BTC2000 is used to assess changes in skin laxity and elasticity in skin that was treated with each closure. Skin maximum pressure, laxity, elastic/viscoelastic/ultimate deformation, and elasticity is measured to track changes through multiple timepoints.
Measured: Baseline, 3 Months, 6 Months, and 12 Months
Histology Collagen 1
Biopsy will be obtained to assess collagen synthesis, restoring dermal strength and elasticity during regeneration fold change= sample/average of the baseline
Measured: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Scar Maximum Depth
eKare will be used to asses scar area
Measured: Week 2, Week 4, Week 6 and Week 8
Interleukin-8 (IL8)
IL8 is a small protein called a chemokine that play a crucial role in the body's immune and inflammatory responses. A biopsy will be obtained at different timepoints to assessment changes from baseline.
fold change= sample/average of the baseline
Measured: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Interleukin-6 (IL6)
IL6 is an inflammatory cytokineses that measures acute phase response following treatment. A biopsy will be obtained at different timepoints to assessment changes from baseline.
fold change= sample/average of the baseline
Measured: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Measure of the Skins Function
TEWL is a skin measurement to objectively measure the skins barrier function. The device measures the rate at which water evaporates from the skins surface
Measured: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Density
Epidermal and Dermis density was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.
Measured: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Thickness
Epidermal and Dermis thickness was measured with a high frequency ultrasound to understand the changes to the structure and composition of the skin.
Measured: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Stiffness
Tissue stiffness was measured using the BTC2000 to measure the resistance of the tissue under applied force/pressure.
Measured: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Energy Absorption
Tissue energy absorption was measured using the BTC2000 to measure the softness of the tissue through the deformation process.
Measured: Baseline, 3 Months, 6 Months, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start5 Oct 2021
- Primary completion4 Apr 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey M. Kenkel, University of Texas Southwestern Medical Center
- Investigators
- Jeffrey Kenkel, MD, Principal investigator, Chairman, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028816
- Sponsor's protocol ID
- STU 2021-0791
- Status last verified
- Jun 2025
- First submitted
- 27 Aug 2021
- Last updated
- 2 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Force Modulating Tissue Bridges for Closure of Vertical Scars in Breast Reduction
- ClinicalTrials.gov ID
- NCT05028816
- Acronym / sponsor ID
- STU 2021-0791
- Conditions
- Surgical Incision
- Keywords
- Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 2 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern
Detailed description
This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern. Subjects will be randomized to the method of closure and wound support of the symmetrical vertical breast incisions. On the intervention side subjects will have FMTBs applied for final layer closure of the vertical breast incision and will continue with repeat application every two weeks for ongoing wound support for a total of 8 weeks of therapy. On the control side standard suture closure and wound dressings will be utilized. Patients will be evaluated at two-week intervals up until 8 weeks post-operative, then will have 3 additional follow up visits at 3-months, 6-months and 12-months post-operatively. The effects of the therapy will be analyzed during the follow up visits through photography, skin assessments and POSAS (Patient and Observer Scar Assessment Scale) results. A subgroup of 10 patients will also undergo biopsies of the area of interest at five time points throughout the study. Primary study outcomes include POSAS results and photographic assessment while secondary outcomes include scar volume/surface area, gene regulation and genetic analysis obtained via biopsies, collagen volume, skin assessments, colorimetry and time of length of adherence of the device.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will occur after all the portions of the surgical procedure are completed except for final skin layer closure.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Side 1: Final layer dermal closure with poliglecaprone 25 suture, Device: Side 2: Final layer closure with force modulating tissue bridges (FMTB)Side 1: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ) Side 2: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA) |
| Group 2 | Other | Device: Side 1: Final layer closure with force modulating tissue bridges (FMTB), Other: Side 2: Final layer dermal closure with poliglecaprone 25 sutureSide 1: Final layer closure with force modulating tissue bridges (FMTB) (Brijjit BP100-6, Brijjit Medical Inc., Marietta, GA) Side 2: Final layer dermal closure with poliglecaprone 25 suture (Monocryl ®, Ethicon, Inc. Bridgewater, NJ) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adult females 18-65 years of age
- Planned procedure is bilateral breast reduction with modified Wise (anchor, inverted "T") scar pattern.
- Ability to adhere wound therapy after surgery for 8 weeks or have a willing family member/partner to assist with wound therapy care.
- Willing to follow wound care therapy as instructed by study staff.
- Willing to return for follow up visits and undergo study evaluations.
Key exclusion criteria (12 listed)
- Individuals diagnosed with known allergy to general adhesives/adhesive tape
- Individuals with a history of using the following prescription medications:
- Individuals who have significant scarring on the test site/area(s)
- Individuals with malnutrition
- Individuals who have a body mass index >35
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 |
|---|---|---|
| Side 1: Final layer closure with force modulating tissue bridges (FMTB)Also: BrijjitBrijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance. | Device | Group 2 |
| Side 1: Final layer dermal closure with poliglecaprone 25 sutureCurrent method of wound closure | Other | Group 1 |
| Side 2: Final layer closure with force modulating tissue bridges (FMTB)Also: BrijjitBrijjit is a non-invasive wound closure device that reduces tension on scars and aids improving scar appearance. | Device | Group 1 |
| Side 2: Final layer dermal closure with poliglecaprone 25 sutureCurrent method of wound closure | Other | Group 2 |
Primary outcome
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M
Time frame: 12 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 6M
Time frame: 6 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 3M
Time frame: 3 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 3M
Time frame: 3 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 12M
Time frame: 12 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
Patient and Observer Scar Assessment Scale (POSAS)- Observer Scores 6M
Time frame: 6 Months
Validated scale used to assess the scar quality after surgery from patient and observer (clinician) prospective. Scoring: Each of the six items on both the Observer and Patient scales is scored on a 10-point numerical rating scale, where: 1 represents tissue that is like normal skin. 10 represents the worst scar imaginable for the observer, or the worst imaginable sensation/difference for the patient. The total score for each scale is the sum of the scores for the six items, ranging from 6 to 60. A higher score indicates a poorer scar quality while a lower scores indicates an ideal scar outcome.
14 secondary outcomes
Scar Area Assessment
Time frame: Week 2, Week 4, Week 6 and Week 8
Gene Regulation- Elastin
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Gene Analysis- Macrophage
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Histology Collagen 3
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Change in Mechanical Properties of Human Tissue
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Histology Collagen 1
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Scar Maximum Depth
Time frame: Week 2, Week 4, Week 6 and Week 8
Interleukin-8 (IL8)
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Interleukin-6 (IL6)
Time frame: Baseline, 4 Week, 8 Week, 3 Months, 12 Months
Measure of the Skins Function
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Density
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Thickness
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Stiffness
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Change in Tissue Energy Absorption
Time frame: Baseline, 3 Months, 6 Months, and 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jeffrey Kenkel, MD principal investigator
Chairman, UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Side 1: Final layer closure with force modulating tissue bridges (FMTB), Side 1: Final layer dermal closure with poliglecaprone 25 suture and Side 2: Final layer closure with force modulating tissue bridges (FMTB) in people with Surgical Incision, run by University of Texas Southwestern Medical Center 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 2 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient and Observer Scar Assessment Scale (POSAS)- Patient Scores 12M (time frame: 12 Months). The study lists 6 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 2 Jul 2025.