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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07573202
Status
Not Yet Recruiting

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Conditions

  • Allergic Contact Dermatitis
  • Hypersensitivity Reactions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jul 30, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: SYLKE® Adhesive Wound Closure
    SYLKE Adhesive Wound Closure is a premium, sterile surgical dressing made from 99.9% medical-grade silk fibroin, designed to approximate and secure wound edges for up to 14 days.
  • Active Comparator: DERMABOND™ PRINEO™ Skin Closure System
    The DERMABOND™ PRINEO™ Skin Closure System is a two-part, topical, sterile medical device used to close surgical incisions and lacerations, combining a 2-octyl cyanoacrylate liquid adhesive with a self-adhering polyester mesh.

Primary Outcome Measure

Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination [ Time Frame: at the time of dressing removal, which is about 10-14 days after the operation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
James M Gregory, MD
[email protected]
(713) 486-7500
Matthew Smith, MD
[email protected]
(713) 486-6536

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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