Silk Scaffold Surgical Incision Dressing

NCT05508945 | Completed Phase 1 FDA Device

• 2 other identifiers: SSSID20204292
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Incision

Keywords

surgical incision dressing; surgical wound dressing; wound coverage; wound dressing; silk; contact dermatitis; SERI scaffold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wound Dressing Detachment

  3 days post operation, 7 days post operation, 14 days post operation

Other Outcomes (1)

• Presence of Infection

  3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation

Study Arms (1)

Surgical Incision

EXPERIMENTAL

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

Device: Dermabond Prineo Skin Closure System; Device: silk; Device: 3M Steri-Strip

Interventions

Dermabond Prineo Skin Closure System 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

Surgical Incision

silk DEVICE

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

Also known as: SERI surgical scaffold

Surgical Incision

3M Steri-Strip DEVICE

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

Surgical Incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mehrdad Mark Mofid: lead

Study Sites (1)

San Diego Skin, Inc.

La Jolla, California, 92037, United States

Location

Related Links

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

MeSH Terms

Conditions

Surgical Wound; Dermatitis, Contact

Condition Hierarchy (Ancestors)

Wounds and Injuries; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Mehrdad Mark Mofid, M.D.

  San Diego Skin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 19, 2022
• Study Start: August 23, 2022
• Primary Completion: August 19, 2023
• Study Completion: August 19, 2023
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available for 1 year after publication.

Locations

US (1)