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Study of Dressings for Shoulder Surgery

This study is looking at two different dressings used after open shoulder surgery: SYLKE (silk fibroin) and Dermabond PRINEO (2-octyl cyanoacrylate mesh). Doctors want to see how often people get an allergic skin reaction (allergic contact dermatitis, or ACD) to each dressing. They also want to understand if one dressing leads to more clinic visits for problems, and how comfortable and satisfied patients are with each dressing. You can join if you are 18 or older and are having open shoulder surgery with Dr. James Gregory or Dr. Robert Fullick. The study will measure the number of people who get ACD when the dressing is removed, about 10-14 days after surgery.

Study design
This study plans to enroll 350 participants. It is an interventional study, meaning participants will receive one of the study dressings.
What's involved
You will have a dressing placed on your wound during surgery. Postoperative appointments at 2 and 6 weeks will include an examination and removal of the dressing.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at the time of dressing removal, which is about 10-14 days after the operation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07573202

Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh in Shoulder Surgery

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
The University of Texas Health Science Center, Houston
~350 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Silk fibroin (SYLKE)2-octyl cyanoacrylate mesh (Dermabond PRINEO)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination
Measured over at the time of dressing removal, which is about 10-14 days after the operation

Conditions

Hypersensitivity Reactions
Allergic Contact Dermatitis

Explore related trials

Shoulder Surgery

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • James M Gregory, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

James M Gregory, MD
[email protected]
(713) 486-7500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

open shoulder procedure with Dr. James Gregory or Dr. Robert Fullick.

Exclusion

Prior documented medical adhesive contact allergy.
Negative pressure wound dressings.
Any procedure involving a wound problem at the planned surgical site.

What this trial measures

  • Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examinationat the time of dressing removal, which is about 10-14 days after the operation

    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