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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Recruitment Status : Withdrawn (Change in research plan)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.

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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Device: Zip Surgical Skin Closure Device: Steel Staples Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02255877


Locations
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United States, Indiana
Orthopaedic Research Foundation
Indianapolis, Indiana, United States, 46278
Sponsors and Collaborators
ZipLine Medical Inc.
Investigators
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Study Director: Eric Storne VP Marketing
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Responsible Party: ZipLine Medical Inc.
ClinicalTrials.gov Identifier: NCT02255877    
Other Study ID Numbers: 005
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Keywords provided by ZipLine Medical Inc.:
Bi lateral knee surgery
uni compartmental