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The Use of Barbed Sutures in Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT02609464
Recruitment Status : Unknown
Verified May 2017 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : November 20, 2015
Last Update Posted : May 18, 2017
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Device: Interrupted Knotted Sutures Device: STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices Not Applicable

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: The Use of Barbed Sutures in Total Hip Arthroplasty: A Prospective, Randomized, and Controlled Clinical Trial
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Inturrupted Knotte Sutures Device: Interrupted Knotted Sutures
Active Comparator: Barbed Sutures Device: STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices



Primary Outcome Measures :
  1. Incidence of suture abscess or other wound related compilation [ Time Frame: Within 30 days of surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT02609464    
Other Study ID Numbers: 15P01
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases