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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Contact Dermatitis; Hypersensitivity Reactions
• Intervention / Treatment: Device: 2-octyl cyanoacrylate mesh (Dermabond PRINEO); Device: Silk fibroin (SYLKE)

Detailed Description

Multiple studies have demonstrated allergic contact dermatitis (ACD) to the Dermabond PRINEO skin closure system (Ethicon, Sommerville, NJ) that utilizes a 2-octyl cyanoacrylate liquid adhesive with a polyester mesh. This dressing is commonly applied after total hip (THA), total knee (TKA), and total shoulder arthroplasty (TSA) as an alternative or adjunct to staples or a subcuticular suture. However, 2-octyl cyanoacrylate mesh is documented to cause an allergic hypersensitivity reaction in 4-5% of patients. Risk factors include a documented contact allergy to medical adhesives and sensitization to 2-octyl cyanoacrylate mesh from a prior surgery. While this ACD generally resolves with dressing removal, corticosteroids, and observation, there are reports of severe reactions to Dermabond PRINEO requiring wound debridement and skin grafting. Despite this complication, Dermabond PRINEO is still one of the most commonly used postoperative dressings in orthopedic surgery. A silk fibroin (SYLKE, La Jolla, CA) dressing has recently been developed as an alternative surgical wound dressing. Two retrospective studies have evaluated the silk dressing compared to cyanoacrylate mesh after THA/TKA. Aastroem et al and Moo Young et al both demonstrated a 0% incidence of ACD with the use of a silk dressing. There is currently no additional evidence to support the use of silk fibroin dressings in orthopedic surgery outside of the total hip and knee literature. Our study will be a randomized controlled trial to prospectively evaluate hypersensitivity reactions to silk fibroin and 2-octyl cyanoacrylate mesh dressings in open shoulder surgery.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James M Gregory, MD; Phone Number: (713) 486-7500; Email: James.M.Gregory@uth.tmc.edu
• Study Contact Backup: Name: Matthew Smith, MD; Phone Number: (713) 486-6536; Email: Matthew.Smith@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: James M Gregory, MD; Phone Number: (713) 486-7500; Email: James.M.Gregory@uth.tmc.edu
      • Contact: Matthew Smith, MD; Phone Number: (713) 486-6536; Email: Matthew.Smith@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinic utilization will be defined as the total number of additional patient communications or visits regarding dressings or wound complications	This will include telephone calls, electronic messages, additional office visits and additional ER visits.	6 weeks after the operation
Patients comfort as assessed by question 6 on the wound experience questionnaire	This is scored from 0(very uncomfortable) to 10 (very comfortable)	2 weeks after the operation
Patients satisfaction as assessed by question 7 on the wound experience questionnaire	This is scored from 0(very dissatisfied) to 10 (very satisfied)	2 weeks after the operation

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: James M Gregory, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hypersensitivity; contact dermatitis; silk fibroin (SYLKE); 2-octyl cyanoacrylate mesh (Dermabond PRINEO); open shoulder surgery
• Additional Relevant MeSH Terms: Immune System Diseases; Skin Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis; Skin and Connective Tissue Diseases; Hypersensitivity; Dermatitis, Contact; Dermatitis, Allergic Contact
• Other Study ID Numbers: HSC-MS-26-0115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No