Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients
1 other identifier
interventional
1,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Oct 2014
Typical duration for not_applicable knee-osteoarthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 8, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedJanuary 31, 2017
January 1, 2017
2.2 years
January 8, 2017
January 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Number of soft tissue infections
evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination
12 weeks
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
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
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
Study Arms (2)
Standard suture
ACTIVE COMPARATORstandard suture used (monocryl)
Barbed suture
ACTIVE COMPARATORbarbed suture used (Quill suture, Surgical Specialties)
Interventions
Eligibility Criteria
You may qualify if:
- primary joint replacement
You may not qualify if:
- no prior joint surgery
- no infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician and Research Chair, Institute for Joint Restoration and Research
Study Record Dates
First Submitted
January 8, 2017
First Posted
January 25, 2017
Study Start
October 1, 2014
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
January 31, 2017
Record last verified: 2017-01