Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients
Primary Purpose
Knee Osteoarthritis, Hip Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
barbed suture
standard suture
Sponsored by
About this trial
This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Joint Replacement, Knee Replacement, Wound Healing, Hip Replacement
Eligibility Criteria
Inclusion Criteria:
- primary joint replacement
Exclusion Criteria:
- no prior joint surgery
- no infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard suture
Barbed suture
Arm Description
standard suture used (monocryl)
barbed suture used (Quill suture, Surgical Specialties)
Outcomes
Primary Outcome Measures
Number of soft tissue infections
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
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
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
record delayed healing and reported by time, suture rejection based on number of episodes
Secondary Outcome Measures
Full Information
NCT ID
NCT03031314
First Posted
January 8, 2017
Last Updated
January 27, 2017
Sponsor
Washington Hospital Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT03031314
Brief Title
Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington Hospital Healthcare System
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Hip Osteoarthritis
Keywords
Joint Replacement, Knee Replacement, Wound Healing, Hip Replacement
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard suture
Arm Type
Active Comparator
Arm Description
standard suture used (monocryl)
Arm Title
Barbed suture
Arm Type
Active Comparator
Arm Description
barbed suture used (Quill suture, Surgical Specialties)
Intervention Type
Device
Intervention Name(s)
barbed suture
Intervention Type
Device
Intervention Name(s)
standard suture
Primary Outcome Measure Information:
Title
Number of soft tissue infections
Description
evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination
Time Frame
12 weeks
Title
use of antibiotics to treat infection, recorded by number
Description
record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded
Time Frame
12 weeks
Title
measurement of incision drainage, measured in grams and mm surface area
Description
evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm
Time Frame
2 weeks
Title
assessment of quality of incision closure, recorded by time and number
Description
record delayed healing and reported by time, suture rejection based on number of episodes
Time Frame
12 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
primary joint replacement
Exclusion Criteria:
no prior joint surgery
no infection
12. IPD Sharing Statement
Learn more about this trial
Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients
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