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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Arthroplasty, Knee Replacement, Wound Healing

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 18 years of age and older Patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty Patients willing to be evaluated at discharge, 2 weeks, and at the 6 to 8 week 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision Appearance / Scar Cosmesis | Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating. Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating. | 6-8 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon Closure Method Satisfaction | Closure method satisfaction will be collected by a 5 point satisfaction scale: Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied A lower score means more satisfaction with the closure method. | 6-8 weeks post op | 
| Patient Pain - Incisional and General | Pain levels will be collected using a 10 point VAS scale. | Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit) | 
| Surgeon and Patient Scar Satisfaction | Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale: Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied | 6 to 8 wk follow up visit | 
| Range of Motion | Knee Range of Motion for each knee will be measured in degrees | 2 weeks and 6-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bi lateral, knee surgery, arthroplasty, orthopedics