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

NCT07573202 | Not Yet Recruiting FDA Device

• 1 other identifier: HSC-MS-26-0115
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypersensitivity Reactions; Allergic Contact Dermatitis

Keywords

silk fibroin (SYLKE); 2-octyl cyanoacrylate mesh (Dermabond PRINEO); open shoulder surgery; hypersensitivity; contact dermatitis

Outcome Measures

Primary Outcomes (1)

• Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination

  ACD will be diagnosed as erythema, with or without weeping or pruritus, in a geometric border at the surgical site and in the absence of fluctuance or purulence

  at the time of dressing removal, which is about 10-14 days after the operation

Secondary Outcomes (3)

• Clinic utilization will be defined as the total number of additional patient communications or visits regarding dressings or wound complications

  6 weeks after the operation

• Patients comfort as assessed by question 6 on the wound experience questionnaire

  2 weeks after the operation

• Patients satisfaction as assessed by question 7 on the wound experience questionnaire

  2 weeks after the operation

Study Arms (2)

SYLKE® Adhesive Wound Closure

EXPERIMENTAL

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.

Device: Silk fibroin (SYLKE)

DERMABOND™ PRINEO™ Skin Closure System

ACTIVE COMPARATOR

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.

Device: 2-octyl cyanoacrylate mesh (Dermabond PRINEO)

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.

SYLKE® Adhesive Wound Closure

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.

DERMABOND™ PRINEO™ Skin Closure System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior documented medical adhesive contact allergy.
• Negative pressure wound dressings.
• Any procedure involving a wound problem at the planned surgical site.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypersensitivity; Dermatitis, Allergic Contact; Dermatitis, Contact

Condition Hierarchy (Ancestors)

Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed

Study Officials

• James M Gregory, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James M Gregory, MD

CONTACT

(713) 486-7500; James.M.Gregory@uth.tmc.edu

Matthew Smith, MD

CONTACT

(713) 486-6536; Matthew.Smith@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)