Surgical IncisionPhase 1SSSIDNCT05508945
Silk Scaffold Surgical Incision Dressing
A Phase 1 study testing Dermabond Prineo Skin Closure System, silk and 3M Steri-Strip in people with Surgical Incision, run by Mehrdad Mark Mofid at 1 site in United States.
Trial summary
Interventional Study of the novel clinical application of SERI surgical silk scaffold affixed with dermaFLEX medical adhesive as a wound dressing, compared to two separate current standard of care for surgical incision closure devices: Prineo Dermabond and 3M Steri-Strip. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Incision
- What is being tested?
- Dermabond Prineo Skin Closure System, silk and 3M Steri-Strip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 19 Aug 2023
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exhibit fluency and literacy in English
- Exhibit adequate cognitive ability to consent to experimental research
- Ability to obtain pre-operative clearance from an unaffiliated primary care physician prior to surgery as deemed necessary under M. Mark Mofid's predetermined standard of care guidelines for patients
Who cannot join
- Diagnosis of autoimmune disorders
- Diagnosis of allergy to DERMABOND Topical Skin Adhesive, STERI-STRIP skin closure strips, polyester mesh, and/or silk
- Any acute or chronic condition that may inhibit ability to participate in the full duration of study
- Inability to give informed consent
- Investigator decision that subject is no a suitable candidate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Silk Scaffold Surgical Incision Dressing Interventional Study
Interventional Study of the novel clinical application of SERI surgical silk scaffold affixed with dermaFLEX medical adhesive as a wound dressing, compared to two separate current standard of care for surgical incision closure devices: Prineo Dermabond and 3M Steri-Strip. Both components of the silk wound dressing prototype are FDA approved materials for other indications. This study seeks to gain insight of functionality of silk as a wound coverage material and determine variations of clinical outcomes in comparison to the synthetic mesh/cyanoacrylate device (Prineo Dermabond) and the nonwoven rayon/acrylate device (3M Steri-Strip) commonly implemented as a surgical wound dressing.
Read the detailed description
Participants for the study will be selected from a population of patients who have voluntarily sought out and consented to cosmetic and/or reconstructive surgery performed by M. Mark Mofid M.D. Patients who request and consent to procedures named in the protocol will be considered for eligibility of participation. Dr. Mofid will make the final determination after a thorough clinical evaluation of the patients medical information. Participants undergoing procedures that result in a single continuous surgical incision will receive the either Prineo Dermabond closure device or 3M Steri-Strip surgical incision closure device on 50% of the surgical incision, and the SERI Scaffold/ dermaFLEX combination on the remaining 50% of the incision. An automated randomization app will be used to determine which side, left or right, will receive each dressing. For an abdominoplasty, the incision typically extends from hip to hip, across the lower abdomen. For this procedure, the Prineo Dermabond or 3M Steri-Strip will be applied from the center of the incision: the belly button, and to the end of the incision, or hip, of the randomly determined side. The SERI Scaffold and dermaFLEX adhesive will be placed on the opposite side of the incision. For procedures that result in separate incisions, such as Breast Reductions, one breast will receive the Prineo Dermabond or 3M Steri-Strip coverage, while the other breast will receive the SERI Scaffold w/ dermaFLEX coverage. The sides will be determined through an automated randomization app. The surgeon, Dr. Mofid, will be informed which side will receive each dressing immediately before the respective dressings are to be applied. The dressings will subsequently be compared and evaluated during post-operative visits. Participants will complete a questionnaire at each designated post-operative visit and answers will be documented.
- Conditions
- Surgical Incision
- Being tested
- Dermabond Prineo Skin Closure System, silk, 3M Steri-Strip
- Keywords
- surgical incision dressing, surgical wound dressing, wound coverage, wound dressing, silk, contact dermatitis, SERI scaffold
- Medical subject headings
- Surgical Wound, Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabond Prineo Skin Closure SystemDevice
synthetic mesh patch is positioned and lightly pressed over 50% of the surgical incision. 2-octyl cyanoacrylate liquid adhesive is evenly applied over the mesh and allowed to dry
silkDevice
Also called SERI surgical scaffold
SERI surgical scaffold with dermaFLEX backing is positioned over the remaining 50% of the surgical incision
3M Steri-StripDevice
non-woven rayon with adhesive backing is applied to 50% of the surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Incision | Experimental | Abdominoplasty Surgical Incision, Breast Reduction Surgical Incision, Mastopexy Surgical Incision, or Belt Lipectomy Surgical Incision Receives: Device: Dermabond Prineo Skin Closure System; Device: silk; Device: 3M Steri-Strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Contact Dermatitis
Participants will self report symptoms of Contact Dermatitis surrounding the treated area quantified on a scaling system of 0-10 based upon the following criteria: Skin Discomfort, Skin Irritation, and Skin Itching.
The Principal Investigator will determine the clinical appearance of Contact Dermatitis surrounding the treated area quantified on a scaling system of 0-10 based upon the following criteria: Skin Rash and Skin Redness
Measured: 3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation
Secondary outcomes (1)
Wound Dressing Detachment
Participants will be evaluated by the Principal Investigator for signs of detached or displaced wound dressings. Participants will self report spontaneous detachment of wound dressing prior to anticipated dressing removal, scheduled 14 days post-operation. The results will be quantified by a measure of "Yes" or "No".
Measured: 3 days post operation, 7 days post operation, 14 days post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start23 Aug 2022
- Primary completion19 Aug 2023
- Study completion19 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- subjects receive 50% surgical incision coverage with experimental silk/adhesive prototype and 50% surgical incision coverage with FDA approved Dermabond Prineo OR FDA approved Steri-Strip.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehrdad Mark Mofid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehrdad Mark Mofid, San Diego Skin, Inc.
- Investigators
- Mehrdad Mark Mofid, M.D., Principal investigator, San Diego Skin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508945
- Sponsor's protocol ID
- SSSID
- Other IDs
- 20204292
- Acronym
- SSSID
- Status last verified
- Apr 2024
- First submitted
- 15 Aug 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Study Protocol and Informed Consent Form will be shared upon completion of trial. Statistical Analysis Plan and Clinical Study Report will be made available 6 months after publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silk Scaffold Surgical Incision Dressing Interventional Study
- ClinicalTrials.gov ID
- NCT05508945
- Acronym / sponsor ID
- SSSID / SSSID
- Conditions
- Surgical Incision
- Keywords
- surgical incision dressing, surgical wound dressing, wound coverage, wound dressing, silk, contact dermatitis, SERI scaffold
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Mehrdad Mark MofidUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 19 Aug 2023 (actual)
- Study completion
- 19 Aug 2023 (actual)
- First posted
- 19 Aug 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.
Interventional Study of the novel clinical application of SERI surgical silk scaffold affixed with dermaFLEX medical adhesive as a wound dressing, compared to two separate current standard of care for surgical incision closure devices: Prineo Dermabond and 3M Steri-Strip. Both components of the silk wound dressing prototype are FDA approved materials for other indications. This study seeks to gain insight of functionality of silk as a wound coverage material and determine variations of clinical outcomes in comparison to the synthetic mesh/cyanoacrylate device (Prineo Dermabond) and the nonwoven rayon/acrylate device (3M Steri-Strip) commonly implemented as a surgical wound dressing.
Detailed description
Participants for the study will be selected from a population of patients who have voluntarily sought out and consented to cosmetic and/or reconstructive surgery performed by M. Mark Mofid M.D. Patients who request and consent to procedures named in the protocol will be considered for eligibility of participation. Dr. Mofid will make the final determination after a thorough clinical evaluation of the patients medical information. Participants undergoing procedures that result in a single continuous surgical incision will receive the either Prineo Dermabond closure device or 3M Steri-Strip surgical incision closure device on 50% of the surgical incision, and the SERI Scaffold/ dermaFLEX combination on the remaining 50% of the incision. An automated randomization app will be used to determine which side, left or right, will receive each dressing. For an abdominoplasty, the incision typically extends from hip to hip, across the lower abdomen. For this procedure, the Prineo Dermabond or 3M Steri-Strip will be applied from the center of the incision: the belly button, and to the end of the incision, or hip, of the randomly determined side. The SERI Scaffold and dermaFLEX adhesive will be placed on the opposite side of the incision. For procedures that result in separate incisions, such as Breast Reductions, one breast will receive the Prineo Dermabond or 3M Steri-Strip coverage, while the other breast will receive the SERI Scaffold w/ dermaFLEX coverage. The sides will be determined through an automated randomization app. The surgeon, Dr. Mofid, will be informed which side will receive each dressing immediately before the respective dressings are to be applied. The dressings will subsequently be compared and evaluated during post-operative visits. Participants will complete a questionnaire at each designated post-operative visit and answers will be documented.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- subjects receive 50% surgical incision coverage with experimental silk/adhesive prototype and 50% surgical incision coverage with FDA approved Dermabond Prineo OR FDA approved Steri-Strip.
| Arm | Type | Receives |
|---|---|---|
| Surgical Incision | Experimental | Device: Dermabond Prineo Skin Closure System, Device: silk, Device: 3M Steri-StripAbdominoplasty Surgical Incision, Breast Reduction Surgical Incision, Mastopexy Surgical Incision, or Belt Lipectomy Surgical Incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Exhibit fluency and literacy in English
- Exhibit adequate cognitive ability to consent to experimental research
- Ability to obtain pre-operative clearance from an unaffiliated primary care physician prior to surgery as deemed necessary under M. Mark Mofid's predetermined standard of care guidelines for patients
Key exclusion criteria (5 listed)
- Diagnosis of autoimmune disorders
- Diagnosis of allergy to DERMABOND Topical Skin Adhesive, STERI-STRIP skin closure strips, polyester mesh, and/or silk
- Any acute or chronic condition that may inhibit ability to participate in the full duration of study
- Inability to give informed consent
- Investigator decision that subject is no a suitable candidate
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 |
|---|---|---|
| Dermabond Prineo Skin Closure Systemsynthetic mesh patch is positioned and lightly pressed over 50% of the surgical incision. 2-octyl cyanoacrylate liquid adhesive is evenly applied over the mesh and allowed to dry | Device | Surgical Incision |
| silkAlso: SERI surgical scaffoldSERI surgical scaffold with dermaFLEX backing is positioned over the remaining 50% of the surgical incision | Device | Surgical Incision |
| 3M Steri-Stripnon-woven rayon with adhesive backing is applied to 50% of the surgical incision. | Device | Surgical Incision |
Primary outcome
Presence of Contact Dermatitis
Time frame: 3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation
Participants will self report symptoms of Contact Dermatitis surrounding the treated area quantified on a scaling system of 0-10 based upon the following criteria: Skin Discomfort, Skin Irritation, and Skin Itching. The Principal Investigator will determine the clinical appearance of Contact Dermatitis surrounding the treated area quantified on a scaling system of 0-10 based upon the following criteria: Skin Rash and Skin Redness
1 secondary outcome
Wound Dressing Detachment
Time frame: 3 days post operation, 7 days post operation, 14 days post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Yes. Study Protocol and Informed Consent Form will be shared upon completion of trial. Statistical Analysis Plan and Clinical Study Report will be made available 6 months after publication.
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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.
Mehrdad Mark Mofid, M.D. principal investigator
San Diego Skin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dermabond Prineo Skin Closure System, silk and 3M Steri-Strip in people with Surgical Incision, run by Mehrdad Mark Mofid 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 3 inclusion and 5 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 18 Apr 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of Contact Dermatitis (time frame: 3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation). 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 18 Apr 2024.