ZIPS Study - Zip Incision Approximation vs. STAPLE

Phase 4

Withdrawn

• Conditions: Arthroplasty, Replacement, Knee
• Interventions: Device: Zip Surgical Skin Closure; Device: Steel Staples

• Registration Number: NCT02255877
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zip Surgical Skin Closure	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
Steel Staples	Steel Staples	Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure
Steel Staples	Zip Surgical Skin Closure	Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure
Zip Surgical Skin Closure	Steel Staples	Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples

Primary Outcome Measures

Name	Time	Method
Effectiveness Outcome - Wound Healing	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

Name	Time	Method
Patient Satisfaction of Scars	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
Patient Pain	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
Surgeon Satisfaction with the Closure Method	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)

Trial Locations

Locations (1)

Orthopaedic Research Foundation; 🇺🇸 Indianapolis, Indiana, United States