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Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031314
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Alexander Sah, MD, Washington Hospital Healthcare System

Brief Summary:

Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries.

The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). The traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless barbed suture and the traditional sutures have similar suture size.

Patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits).

Secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Hip Osteoarthritis Device: barbed suture Device: standard suture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard suture
standard suture used (monocryl)
Device: standard suture
Active Comparator: Barbed suture
barbed suture used (Quill suture, Surgical Specialties)
Device: barbed suture



Primary Outcome Measures :
  1. Number of soft tissue infections [ Time Frame: 12 weeks ]
    evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination

  2. use of antibiotics to treat infection, recorded by number [ Time Frame: 12 weeks ]
    record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded

  3. measurement of incision drainage, measured in grams and mm surface area [ Time Frame: 2 weeks ]
    evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm

  4. assessment of quality of incision closure, recorded by time and number [ Time Frame: 12 weeks ]
    record delayed healing and reported by time, suture rejection based on number of episodes



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary joint replacement

Exclusion Criteria:

  • no prior joint surgery
  • no infection
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Responsible Party: Alexander Sah, MD, Physician and Research Chair, Institute for Joint Restoration and Research, Washington Hospital Healthcare System
ClinicalTrials.gov Identifier: NCT03031314    
Other Study ID Numbers: WHHSIJRR001
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Keywords provided by Alexander Sah, MD, Washington Hospital Healthcare System:
Joint Replacement
Knee Replacement
Wound Healing
Hip Replacement
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases