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

October 21, 2016 updated by: ZipLine Medical Inc.

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 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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46278
        • Orthopaedic Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 8i
  • Zip 16
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 8i
  • Zip 16
Device: Steel Staples
Skin Closure device for the closure of the skin layer for surgical incisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At Discharge, 1-3 days post surgery
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
Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)
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
At 6 week Follow up (exit) visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZipLine Medical Inc.

Investigators

  • Study Director: Eric Storne, VP Marketing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 24, 2016

Last Update Submitted That Met QC Criteria

October 21, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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