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ZIPS Study - Zip Incision Approximation vs. STAPLE (ZIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255877
Recruitment Status : Withdrawn (Change in research plan)
First Posted : October 3, 2014
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
ZipLine Medical Inc.

Tracking Information
First Submitted Date  ICMJE September 26, 2014
First Posted Date  ICMJE October 3, 2014
Last Update Posted Date October 24, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
Effectiveness Outcome - Wound Healing [ Time Frame: 6 weeks post surgery ]
Wound healing as judged by the Cosmetic Visual Analogue Scale - Photos taken at 6 weeks post surgery will be judged by panel of Plastic Surgeons blinded to the treatment assignments.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
  • Surgeon Satisfaction with the Closure Method [ Time Frame: At Discharge, 1-3 days post surgery ]
    Closure Method satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied)
  • Patient Pain [ Time Frame: Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.) ]
    General post operative and incisional pain levels will be collected using a 10 point VAS scale
  • Patient Satisfaction of Scars [ Time Frame: At 6 week Follow up (exit) visit ]
    Scar satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied) and with a 10 point VAS scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ZIPS Study - Zip Incision Approximation vs. STAPLE
Official Title  ICMJE A Prospective, Non Blinded, Randomized Controlled Post Market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device vs. Conventional Steel Staples for Skin Closure in Subjects Who Undergo a bi Lateral Knee Arthroplasty
Brief Summary Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.
Detailed Description This is a randomized, within patient control study aiming to enroll up to 25 subjects requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center. Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and overall satisfaction of closure methods.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthroplasty, Replacement, Knee
Intervention  ICMJE
  • Device: Zip Surgical Skin Closure
    Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.
    Other Names:
    • Zip 16
    • Zip 8i
  • Device: Steel Staples
    Skin Closure device for the closure of the skin layer for surgical incisions.
Study Arms  ICMJE
  • Active Comparator: Zip Surgical Skin Closure
    Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples
    Interventions:
    • Device: Zip Surgical Skin Closure
    • Device: Steel Staples
  • Active Comparator: Steel Staples
    Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure
    Interventions:
    • Device: Zip Surgical Skin Closure
    • Device: Steel Staples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 21, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2014)
25
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty;
  • Patients willing to be evaluated at discharge and 6-weeks post op.

Exclusion Criteria:

  • Known bleeding disorder not caused by medication
  • Known personal or family history of keloid formation or scar hypertrophy
  • Known allergy or hypersensitivity to non-latex skin adhesives
  • Atrophic skin deemed clinically prone to blistering
  • Any skin disorder affecting wound healing
  • Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02255877
Other Study ID Numbers  ICMJE 005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ZipLine Medical Inc.
Study Sponsor  ICMJE ZipLine Medical Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Storne VP Marketing
PRS Account ZipLine Medical Inc.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP