Hypersensitivity ReactionsNCT07573202
Evaluation of Hypersensitivity Reactions to Silk Fibroin Versus 2-octyl Cyanoacrylate Mesh in Shoulder Surgery
A study testing Silk fibroin (SYLKE) and 2-octyl cyanoacrylate mesh (Dermabond PRINEO) in people with Hypersensitivity Reactions and Allergic Contact Dermatitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity Reactions, Allergic Contact Dermatitis
- What is being tested?
- Silk fibroin (SYLKE) and 2-octyl cyanoacrylate mesh (Dermabond PRINEO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 30 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- open shoulder procedure with Dr. James Gregory or Dr. Robert Fullick.
Who cannot join
- Prior documented medical adhesive contact allergy.
- Negative pressure wound dressings.
- Any procedure involving a wound problem at the planned surgical site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
James M Gregory, MD, (713) 486-7500, James.M.Gregory@uth.tmc.edu
Matthew Smith, MD, (713) 486-6536, Matthew.Smith@uth.tmc.edu
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Silk fibroin (SYLKE), 2-octyl cyanoacrylate mesh (Dermabond PRINEO)
- Keywords
- silk fibroin (SYLKE), 2-octyl cyanoacrylate mesh (Dermabond PRINEO), open shoulder surgery, hypersensitivity, contact dermatitis
- Medical subject headings
- Hypersensitivity, Dermatitis, Allergic Contact, Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Silk fibroin (SYLKE) |
| 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. Receives: Device: 2-octyl cyanoacrylate mesh (Dermabond PRINEO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the time of dressing removal, which is about 10-14 days after the operation
Secondary outcomes (3)
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.
Measured: 6 weeks after the operation
Patients comfort as assessed by question 6 on the wound experience questionnaire
This is scored from 0(very uncomfortable) to 10 (very comfortable)
Measured: 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)
Measured: 2 weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersensitivity ReactionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James M. Gregory, The University of Texas Health Science Center, Houston
- Investigators
- James M Gregory, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573202
- Sponsor's protocol ID
- HSC-MS-26-0115
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No