Silk Scaffold Surgical Incision Dressing

Surgical Incision Clinical Trial

— SSSID  

Official title:

Silk Scaffold Surgical Incision Dressing Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508945
• Other study ID #: SSSID
• Secondary ID: 20204292
• Status: Completed
• Phase: Phase 1
• Start date: August 23, 2022
• Est. completion date: August 19, 2023

Study information

• Verified date: April 2024
• Source: San Diego Skin, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: August 19, 2023
• Est. primary completion date: August 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Incision
• Surgical Wound

Intervention

Device:
• 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
• silk
SERI surgical scaffold with dermaFLEX backing is positioned over the remaining 50% of the surgical incision
• 3M Steri-Strip
non-woven rayon with adhesive backing is applied to 50% of the surgical incision.

Locations

Country	Name	City	State
United States	San Diego Skin, Inc.	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Mehrdad Mark Mofid

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence of Infection	The Principal Investigator will evaluate presence of infection at the surgical site based upon the standard clinical evidence of infection. The results will be quantified by a measure of "Yes" or "No".	3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation
Primary	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	3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation
Secondary	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".	3 days post operation, 7 days post operation, 14 days post operation

External Links

•   Silkworm silk-based materials and devices generated using bio-nanotechnology