Use of Silk Fibroin Dressings in Primary Total Hip Arthroplasty

NCT07868900 | Not Yet Recruiting FDA Device

• 1 other identifier: HSC-MS-26-0703
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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, to document the incidence of acute wound dehiscence requiring reoperation after application of silk fibroin and 2-octyl cyanoacrylate mesh dressings, 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 after total hip arthroplasty.

Conditions

Allergic Contact Dermatitis (ACD)

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (2)

• Number of participants with allergic contact dermatitis (ACD) to dressings as assessed by clinical examination by a blinded observer at dressing removal

  ACD includes erythema, with or without weeping or pruritus, in a geometric border at the surgical site with absence of fluctuance or purulence

  At the time of dressing removal about 10-14 days after surgery

• Number of participants with acute wound dehiscence resulting in reoperation

  within 6 weeks of index procedure

Secondary Outcomes (3)

• Clinic utilization as assessed by the the total number of additional patient communications or visits regarding dressings or wound complications.

  6-8 weeks after the operation

• Patient overall comfort as assessed by question 6 on the Patient Reported Outcomes (PROMs) questionnaire .

  2-4 weeks after the operation

• Patient satisfaction with the dressing as assessed by question 7 on the Patient Reported Outcomes (PROMs) questionnaire .

  2-4 weeks after the operation

Study Arms (2)

Dermabond PRINEO skin closure system

ACTIVE COMPARATOR

Device: Dermabond PRINEO

Silk fibroin wound dressing

EXPERIMENTAL

Device: Silk fibroin

Interventions

Dermabond PRINEO DEVICE

Participants will have the Dermabond PRINEO wound dressing applied after surgery and will undergo standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound. Photos of the surgical wound will be uploaded to the patient's electronic medical record during dressing removal.

Dermabond PRINEO skin closure system

Silk fibroin DEVICE

Participants will have the Silk fibroin wound dressing applied after surgery and will undergo standard postoperative examination that will evaluate and remove the dressing, as well as examine and document a physical examination of the surgical wound. Photos of the surgical wound will be uploaded to the patient's electronic medical record during dressing removal.

Silk fibroin wound dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary total hip arthroplasty performed by Dr. Rodriguez, Dr. Freedhand or Dr. Shahi

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77479, United States

Location

MeSH Terms

Conditions

Dermatitis, Allergic Contact

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• David Rodriguez-Quintana, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Rodriguez-Quintana, MD

CONTACT

(713) 486-7500; David.RodriguezQuintana@uth.tmc.edu

Ethan Sij

CONTACT

940-399-3314; Ethan.W.Sij@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Non-Tenure Clinical

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)