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

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031314
• Other study ID #: WHHSIJRR001
• Status: Completed
• Phase: N/A
• First received: January 8, 2017
• Last updated: January 27, 2017
• Start date: October 2014
• Est. completion date: January 1, 2017

Study information

• Verified date: January 2017
• Source: Washington Hospital Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 1, 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• primary joint replacement

Exclusion Criteria:

• no prior joint surgery

• no infection

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Device:
• barbed suture

• standard suture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington Hospital Healthcare System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of soft tissue infections	evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination	12 weeks
Primary	use of antibiotics to treat infection, recorded by number	record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded	12 weeks
Primary	measurement of incision drainage, measured in grams and mm surface area	evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm	2 weeks
Primary	assessment of quality of incision closure, recorded by time and number	record delayed healing and reported by time, suture rejection based on number of episodes	12 weeks