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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
Washington Hospital Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 8, 2017
    Last Updated
    January 27, 2017
    Sponsor
    Washington Hospital Healthcare System
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    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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