Clinical trial NCT05508945: Silk Scaffold Surgical Incision Dressing
Official title: Silk Scaffold Surgical Incision Dressing Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Surgical Incision
Keywords: surgical incision dressing
surgical wound dressing
wound coverage
wound dressing
silk
contact dermatitis
SERI scaffold
Lead sponsor: San Diego Skin, Inc.
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Contact Dermatitis
timeFrame: 3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation
Secondary outcomes:
measure: Wound Dressing Detachment
timeFrame: 3 days post operation, 7 days post operation, 14 days post operation
Other outcomes:
measure: Presence of Infection
timeFrame: 3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation
Locations:
city: La Jolla
country: United States
facility: San Diego Skin, Inc.
state: California
Study officials:
affiliation: San Diego Skin
name: Mehrdad Mark Mofid, M.D.
role: PRINCIPAL_INVESTIGATOR
References: