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Silk Scaffold Surgical Incision Dressing

NCT05508945 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-04-18

No results posted yet for this study

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

Interventions

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

DEVICE

3M Steri-Strip

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

Sponsors & Collaborators

  • Mehrdad Mark Mofid

    lead OTHER

Principal Investigators

  • Mehrdad Mark Mofid, M.D. · San Diego Skin

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2023-08-19
Completion
2023-08-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508945 on ClinicalTrials.gov