ZIPS Study - Zip Incision Approximation vs. STAPLE

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: Zip Surgical Skin Closure
* Device: Steel Staples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zip Surgical Skin Closure<br>Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples | Device: Zip Surgical Skin Closure<br>* Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.<br>* Other names: Zip 8i;Device: Steel Staples<br>* Skin Closure device for the closure of the skin layer for surgical incisions.<br>|
| Active Comparator: Steel Staples<br>Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure | Device: Zip Surgical Skin Closure<br>* Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.<br>* Other names: Zip 8i;Device: Steel Staples<br>* Skin Closure device for the closure of the skin layer for surgical incisions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | At 6 week Follow up (exit) visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bi lateral knee surgery, uni compartmental