Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh in Shoulder Surgery
11. mai 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
350
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: James M Gregory, MD
- Telefonnummer: (713) 486-7500
- E-post: James.M.Gregory@uth.tmc.edu
Studer Kontakt Backup
- Navn: Matthew Smith, MD
- Telefonnummer: (713) 486-6536
- E-post: Matthew.Smith@uth.tmc.edu
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77030
- The University of Texas Health Science Center at Houston
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Ta kontakt med:
- James M Gregory, MD
- Telefonnummer: (713) 486-7500
- E-post: James.M.Gregory@uth.tmc.edu
-
Ta kontakt med:
- Matthew Smith, MD
- Telefonnummer: (713) 486-6536
- E-post: Matthew.Smith@uth.tmc.edu
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinic utilization will be defined as the total number of additional patient communications or visits regarding dressings or wound complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: James M Gregory, MD, The University of Texas Health Science Center, Houston
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. juni 2026
Primær fullføring (Antatt)
30. juni 2028
Studiet fullført (Antatt)
30. juli 2028
Datoer for studieregistrering
Først innsendt
1. mai 2026
Først innsendt som oppfylte QC-kriteriene
1. mai 2026
Først lagt ut (Faktiske)
7. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSC-MS-26-0115
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
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