Silk Fibroin Dressings for Allergic Contact Dermatitis

DR
ES
Overseen ByEthan Sij
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to document the incidence of allergic contact dermatitis (ACD) to silk fibroin and 2-octyl cyanoacrylate mesh dressings, to document the incidence of acute wound dehiscence requiring reoperation after application of silk fibroin and 2-octyl cyanoacrylate mesh dressings, to identify differences in clinic utilization for complications related to silk fibroin and 2-octyl cyanoacrylate mesh dressings and to collect patient reported outcome measures (PROMs) related to patient comfort and satisfaction for silk fibroin and 2-octyl cyanoacrylate mesh dressings after total hip arthroplasty.

Who Is on the Research Team?

DR

David Rodriguez-Quintana, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for people having their first total hip replacement surgery. It focuses on those who need a wound dressing after the operation and want to help study skin reactions or healing issues from different dressings.

Inclusion Criteria

I had my hip replacement surgery done by Dr. Rodriguez, Dr. Freedhand, or Dr. Shahi.

Exclusion Criteria

Prior documented medical adhesive contact allergy
Use of negative pressure wound dressings
I have a wound problem at the site where surgery is planned.

What Are the Treatments Tested in This Trial?

Interventions

  • Dermabond PRINEO
  • Silk fibroin

Trial Overview

The study compares two types of wound dressings—silk fibroin and Dermabond PRINEO (a mesh with medical glue)—to see which causes fewer allergic skin reactions, wound problems, or complications after hip replacement surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Silk fibroin wound dressingExperimental Treatment1 Intervention
Group II: Dermabond PRINEO skin closure systemActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+