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Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02460172
Recruitment Status : Completed
First Posted : June 2, 2015
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
ZipLine Medical Inc.

Study Description
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Brief Summary:
Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.

Condition or disease Intervention/treatment Phase
Arthroplasty, Knee Replacement Wound Healing Device: Zip Surgical Skin Closure Device: Steel Staples Not Applicable

Detailed Description:
Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Post-market Study to Compare the Use of the Zip® Surgical Skin Closure Device Versus Conventional Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
Actual Study Start Date : May 2015
Actual Primary Completion Date : February 15, 2017
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Zip Surgical Skin Closure
Subject will be randomized to receive one knee (right or left) closed with Zip Surgical Skin Closure and the other knee closed with steel staples.
 Device: Zip Surgical Skin Closure
Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
Other Names:
  • Zip16
  • Zip 8i
Active Comparator: Steel Staples
Subject will be randomized to receive one knee (right or left) closed with steel staples and the other knee closed with Zip Surgical Skin Closure.
 Device: Steel Staples
Skin closure device for the closure of the skin layer following surgical incision
Other Name: Conventional staples


Outcome Measures
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Primary Outcome Measures :
  1. Incision Appearance / Scar Cosmesis [ Time Frame: 6-8 weeks post surgery ]

    Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating.

    Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating.

    Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating.



Secondary Outcome Measures :
  1. Surgeon Closure Method Satisfaction [ Time Frame: 6-8 weeks post op ]

    Closure method satisfaction will be collected by a 5 point satisfaction scale:

    1. Very Satisfied
    2. Satisfied
    3. Neither
    4. Dissatisfied
    5. Very Dissatisfied A lower score means more satisfaction with the closure method.

  2. Patient Pain - Incisional and General [ Time Frame: Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit) ]
    Pain levels will be collected using a 10 point VAS scale.

  3. Surgeon and Patient Scar Satisfaction [ Time Frame: 6 to 8 wk follow up visit ]

    Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale:

    Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied


  4. Range of Motion [ Time Frame: 2 weeks and 6-8 weeks ]
    Knee Range of Motion for each knee will be measured in degrees


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients 18 years of age and older
  2. Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty
  3. Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week post op

Exclusion Criteria:

  1. Known bleeding disorder not caused by medication
  2. Known personal or family history of keloid formation or scar hypertrophy
  3. Known allergy or hypersensitivity to non-latex skin adhesives
  4. Atrophic skin deemed clinically prone to blistering
  5. Any skin disorder affecting wound healing
  6. Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460172


Locations
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United States, Indiana
Shelbourne Knee Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
ZipLine Medical Inc.
Investigators
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Principal Investigator: Rodney Benner, MD Study Center
  Study Documents (Full-Text)

Documents provided by ZipLine Medical Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] April 21, 2015

More Information
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Responsible Party: ZipLine Medical Inc.
ClinicalTrials.gov Identifier: NCT02460172    
Other Study ID Numbers: 006
First Posted: June 2, 2015    Key Record Dates
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ZipLine Medical Inc.:
bi lateral
knee surgery
arthroplasty
orthopedics