Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients
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|ClinicalTrials.gov Identifier: NCT03031314|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 31, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|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|
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
- 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
- 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
- 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
- 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