Silk Scaffold Surgical Incision Dressing (SSSID)

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.

Study Overview

• Status: Completed
• Conditions: Surgical Incision
• Intervention / Treatment: Device: Dermabond Prineo Skin Closure System; Device: silk; Device: 3M Steri-Strip

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • San Diego Skin, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Surgical Incision; Abdominoplasty Surgical Incision, Breast Reduction Surgical Incision, Mastopexy Surgical Incision, or Belt Lipectomy Surgical Incision

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mehrdad Mark Mofid
• Investigators: Principal Investigator: Mehrdad Mark Mofid, M.D., San Diego Skin

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): August 19, 2023
• Study Completion (Actual): August 19, 2023

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: contact dermatitis; silk; surgical incision dressing; surgical wound dressing; wound coverage; wound dressing; SERI scaffold
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: SSSID; 20204292 (Other Identifier: WCG IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available for 1 year after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes