Status:
WITHDRAWN
ZIPS Study - Zip Incision Approximation vs. STAPLE
Lead Sponsor:
ZipLine Medical Inc.
Conditions:
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 follo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02255877
Start Date
September 1 2014
End Date
September 1 2014
Last Update
October 24 2016
Active Locations (1)
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1
Orthopaedic Research Foundation
Indianapolis, Indiana, United States, 46278