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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Interventions: Device: barbed suture; Device: standard suture

• Registration Number: NCT03031314
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2016-12
• Status Verified: 2017-01
• Study Completion: 2017-01-01
• Study First Submitted: 2017-01-08
• Study First Submitted QC: 2017-01-21
• Study First Posted: 2017-01-25
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• primary joint replacement

Exclusion Criteria

• no prior joint surgery
• no infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Barbed suture	barbed suture	barbed suture used (Quill suture, Surgical Specialties)
Standard suture	standard suture	standard suture used (monocryl)

Primary Outcome Measures

Name	Time	Method
Number of soft tissue infections	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	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	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	12 weeks	record delayed healing and reported by time, suture rejection based on number of episodes