Silk Fibroin vs 2-octyl Cyanoacrylate for Contact Dermatitis

JM
MS
Overseen ByMatthew Smith, MD
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 after open shoulder surgery, 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.

Who Is on the Research Team?

JM

James M Gregory, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

Inclusion Criteria

I am having open shoulder surgery with Dr. Gregory or Dr. Fullick.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo open shoulder surgery and receive either silk fibroin or 2-octyl cyanoacrylate mesh dressings

10-14 days
1 visit (in-person) for surgery and dressing application

Follow-up

Participants are monitored for allergic contact dermatitis and other complications related to dressings

6 weeks
Multiple visits (in-person and virtual) for monitoring and assessment

What Are the Treatments Tested in This Trial?

Interventions

  • 2-octyl Cyanoacrylate Mesh
  • Silk Fibroin

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: SYLKE dressingExperimental Treatment1 Intervention
Group II: Dermabond PRINEO dressingActive 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+