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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Hip Osteoarthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

primary joint replacement

Exclusion criteria

no prior joint surgery
no infection

Treatment and study plan

barbed suture

Device

standard suture

Device

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Washington Hospital Healthcare System

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Jan 25, 2017
Registry last updated: Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed