Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh in Shoulder Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About 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.

Eligibility criteria

Qualifiers

open shoulder procedure with Dr. James Gregory or Dr. Robert Fullick.

Disqualifiers

Prior documented medical adhesive contact allergy.

Negative pressure wound dressings.

Any procedure involving a wound problem at the planned surgical site.

Trial design

Treatments tested in this trial

  • Silk fibroin (SYLKE)
  • 2-octyl cyanoacrylate mesh (Dermabond PRINEO)

Treatment groups

350 Participants
are divided into 2 treatment groups