Silk Scaffold Surgical Incision Dressing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2023-08-19

Brief Summary

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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.

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Detailed Description

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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

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Surgical Incision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Participants are not informed which dressing is Dermabond Prineo and which is SERI scaffold with dermaFLEX adhesive. Participants are informed they will be receiving both interventions

Study Groups

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Surgical Incision

Abdominoplasty Surgical Incision, Breast Reduction Surgical Incision, Mastopexy Surgical Incision, or Belt Lipectomy Surgical Incision

Group Type EXPERIMENTAL

Dermabond Prineo Skin Closure System

Intervention Type DEVICE

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

silk

Intervention Type DEVICE

SERI surgical scaffold with dermaFLEX backing is positioned over the remaining 50% of the surgical incision

3M Steri-Strip

Intervention Type DEVICE

non-woven rayon with adhesive backing is applied to 50% of the surgical incision.

Interventions

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Dermabond Prineo Skin Closure System

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

Intervention Type DEVICE

silk

SERI surgical scaffold with dermaFLEX backing is positioned over the remaining 50% of the surgical incision

Intervention Type DEVICE

3M Steri-Strip

non-woven rayon with adhesive backing is applied to 50% of the surgical incision.

Intervention Type DEVICE

Other Intervention Names

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SERI surgical scaffold

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes