Dermabond Prineo Skin Closure System for Surgical Incisions

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
San Diego Skin, Inc., La Jolla, CA
Surgical Incisions+1 More
Dermabond Prineo Skin Closure System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Surgical Incisions

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Surgical Incisions

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation

Day 14
Wound Dressing Detachment
Day 42
Presence of Contact Dermatitis
Presence of Infection

Trial Safety

Safety Progress

1 of 3

Other trials for Surgical Incisions

Trial Design

1 Treatment Group

Surgical Incision
1 of 1
Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Dermabond Prineo Skin Closure System · No Placebo Group · Phase 1

Surgical IncisionExperimental Group · 3 Interventions: 3M Steri-Strip, Dermabond Prineo Skin Closure System, silk · Intervention Types: Device, Device, Device

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation
Closest Location: San Diego Skin, Inc. · La Jolla, CA
Photo of La Jolla 1Photo of La Jolla 2Photo of La Jolla 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Surgical Incisions
0 CompletedClinical Trials

Who is running the clinical trial?

Mehrdad Mark MofidLead Sponsor
Mehrdad Mark Mofid, M.D.Principal InvestigatorSan Diego Skin

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to obtain pre-operative clearance from an unaffiliated primary care physician prior to surgery as deemed necessary under M

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.