An interventional study of Silk fibroin (SYLKE) and 2-octyl cyanoacrylate mesh (Dermabond PRINEO) in Hypersensitivity Reactions and Allergic Contact Dermatitis, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Supportive care
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.
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.
52 studies on the registry are indexed under Dermatitis, Allergic Contact; 11 are open to participants now.
This study's planned enrollment of 350 is above the median of 45 across 41 interventional studies indexed under Dermatitis, Allergic Contact.
Browse Dermatitis, Allergic Contact studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Compared within Dermatitis, Allergic Contact, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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)
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)
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.
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.
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
Time frame: at the time of dressing removal, which is about 10-14 days after the operation
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.
Time frame: 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)
Time frame: 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)
Time frame: 2 weeks after the operation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Jun 2028, 24 months later.
Of 14 interventional studies with no phase under Dermatitis, Allergic Contact, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 21. This study's planned 24 months is above that.
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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