Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh in Shoulder Surgery
11 maj 2026 uppdaterad av: James M. Gregory, The University of Texas Health Science Center, Houston
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
350
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: James M Gregory, MD
- Telefonnummer: (713) 486-7500
- E-post: James.M.Gregory@uth.tmc.edu
Studera Kontakt Backup
- Namn: Matthew Smith, MD
- Telefonnummer: (713) 486-6536
- E-post: Matthew.Smith@uth.tmc.edu
Studieorter
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Texas
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Houston, Texas, Förenta staterna, 77030
- The University of Texas Health Science Center at Houston
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Kontakt:
- James M Gregory, MD
- Telefonnummer: (713) 486-7500
- E-post: James.M.Gregory@uth.tmc.edu
-
Kontakt:
- Matthew Smith, MD
- Telefonnummer: (713) 486-6536
- E-post: Matthew.Smith@uth.tmc.edu
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
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Aktiv komparator: 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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination
Tidsram: at the time of dressing removal, which is about 10-14 days after the operation
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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
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at the time of dressing removal, which is about 10-14 days after the operation
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Clinic utilization will be defined as the total number of additional patient communications or visits regarding dressings or wound complications
Tidsram: 6 weeks after the operation
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This will include telephone calls, electronic messages, additional office visits and additional ER visits.
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6 weeks after the operation
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Patients comfort as assessed by question 6 on the wound experience questionnaire
Tidsram: 2 weeks after the operation
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This is scored from 0(very uncomfortable) to 10 (very comfortable)
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2 weeks after the operation
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Patients satisfaction as assessed by question 7 on the wound experience questionnaire
Tidsram: 2 weeks after the operation
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This is scored from 0(very dissatisfied) to 10 (very satisfied)
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2 weeks after the operation
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: James M Gregory, MD, The University of Texas Health Science Center, Houston
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 juni 2026
Primärt slutförande (Beräknad)
30 juni 2028
Avslutad studie (Beräknad)
30 juli 2028
Studieregistreringsdatum
Först inskickad
1 maj 2026
Först inskickad som uppfyllde QC-kriterierna
1 maj 2026
Första postat (Faktisk)
7 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HSC-MS-26-0115
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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