Sponsor study identifier
interventional
350
1 country
1
Study Start
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2026
Actual (reported)May 7, 2026
Actual (reported)June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Clinic utilization will be defined as the total number of additional patient communications or visits regarding dressings or wound complications
6 weeks after the operation
Patients comfort as assessed by question 6 on the wound experience questionnaire
2 weeks after the operation
Patients satisfaction as assessed by question 7 on the wound experience questionnaire
2 weeks after the operation
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.
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.
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.
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
James M Gregory, MD
The University of Texas Health Science Center, Houston
First Submitted
May 1, 2026
First Posted
May 7, 2026
Study Start
June 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents
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June 30, 2028
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 14, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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