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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.
Skin Closure device for the closure of the skin layer for surgical incisions.
Orthopaedic Research Foundation
Indianapolis, Indiana, United States
Effectiveness Outcome - Wound Healing
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.
Time frame: 6 weeks post surgery
Surgeon Satisfaction with the Closure Method
Closure Method satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied)
Time frame: At Discharge, 1-3 days post surgery
Patient Pain
General post operative and incisional pain levels will be collected using a 10 point VAS scale
Time frame: Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)
Patient Satisfaction of Scars
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
Time frame: At 6 week Follow up (exit) visit
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