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NCT02609464 Clinical Trial

The Use of Barbed Sutures in Total Hip Arthroplasty

Osteoarthritis, Hip Clinical Trial

Official title:
The Use of Barbed Sutures in Total Hip Arthroplasty: A Prospective, Randomized, and Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02609464
Other study ID # 15P01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2015
Est. completion date March 1, 2020

Study information
Verified date September 2023
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the role of new barbed suture for closure of wound during total hip arthroplasty in reducing the risk for wound healing problems.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - All patients receiving elective primary THA through the direct anterior approach, treated by the primary investigator (JP) at the Thomas Jefferson University Hospital or Rothman Specialty Hospital. Exclusion Criteria: - Prior surgical incision or scar in close proximity of the proposed incision (<2 cm). - Local skin conditions such as dermatitis, eczema, or psoriasis. - Active or previous infection in the skin or the hip. - Inflammatory arthritis; connective tissue or vascular disorders or diseases that would adversely affect wound healing including the use of oral or topical cortico-steroid use

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Interrupted Knotted Sutures

• STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics Ethicon, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of suture abscess or other wound related compilation Within 30 days of surgery
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