NCT02255877

ZIPS Study - Zip Incision Approximation vs. STAPLE

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ZipLine Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthroplasty, Replacement, Knee

Interventions

Type	Name	Description
DEVICE	Zip Surgical Skin Closure	Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.
DEVICE	Steel Staples	Skin Closure device for the closure of the skin layer for surgical incisions.

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-10-03
• Last updated: 2016-10-24

Locations

1 site across 1 country: United States