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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| James M Gregory, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| 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. |
|
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 |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D017449 | Dermatitis, Allergic Contact |
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006968 | Hypersensitivity, Delayed |
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