ZIPS Study - Zip Incision Approximation vs. STAPLE



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:7/11/2015
Start Date:September 2014
End Date:October 2015
Contact:Eric Storne
Email:estorne@ziplinemedical.com
Phone:408.684.0747

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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.

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
We found this trial at
1
site
Orthopaedic Research Foundation
Indianapolis, Indiana 46278
?
mi
from
Indianapolis, IN
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