Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07573202

Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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

Secondary outcomes

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

    Time frame: 6 weeks after the operation

    This will include telephone calls, electronic messages, additional office visits and additional ER visits.

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

    Time frame: 2 weeks after the operation

    This is scored from 0(very uncomfortable) to 10 (very comfortable)

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

    Time frame: 2 weeks after the operation

    This is scored from 0(very dissatisfied) to 10 (very satisfied)

Study contacts

Contact information is provided by the study sponsor or research team.

James M Gregory, MD

CONTACT

[email protected]

(713) 486-7500

Matthew Smith, MD

CONTACT

[email protected]

(713) 486-6536

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 7, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.