NCT02460172

Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty

A Prospective, Randomized Controlled Post-market Study to Compare the Use of the Zip® Surgical Skin Closure Device Versus Conventional Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: ZipLine Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.

Detailed description

Prospective, randomized, within patient control study comparing the use of Zip Surgical Skin Closure device versus conventional staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi lateral total knee replacement. A total of up to 25 patients will be enrolled and followed for up to 8 weeks post surgery to evaluate wound healing and overall satisfaction of closure method.

Conditions

• Arthroplasty, Knee Replacement
• Wound Healing

Interventions

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

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-02-15
• Completion: 2017-02-15
• First posted: 2015-06-02
• Last updated: 2019-03-05
• Results posted: 2019-03-05

Locations

1 site across 1 country: United States