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NOT YET RECRUITING
NCT07573202
NA

Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh a Randomized Controlled Trial to Evaluate Hypersensitivity Reactions in Shoulder Surgery

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2026-06-30

Completion Date

2028-07-30

Last Updated

2026-05-07

Healthy Volunteers

No

Interventions

DEVICE

silk fibroin (SYLKE)

SYLKE dressing will be placed in a sealed envelope, which will be opened by the operative surgeon during wound closure and placed on the closed wound. 2 week and 6 week postoperative appointments will include a standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound.

DEVICE

2-octyl cyanoacrylate mesh (Dermabond PRINEO)

Dermabond PRINEO dressing will be placed in a sealed envelope, which will be opened by the operative surgeon during wound closure and placed on the closed wound. 2 week and 6 week postoperative appointments will include a standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound.

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States