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

Not Applicable

Completed

• Conditions: Wound Healing; Arthroplasty, Knee Replacement
• Interventions: Device: Zip Surgical Skin Closure; Device: Steel Staples

• Registration Number: NCT02460172
• Lead Sponsor: ZipLine Medical Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-02
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-15
• Results First Submitted: 2018-11-26
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-11
• Last Update Submitted: 2019-02-11
• Results First Posted: 2019-03-05
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

1. Known bleeding disorder not caused by medication
2. Known personal or family history of keloid formation or scar hypertrophy
3. Known allergy or hypersensitivity to non-latex skin adhesives
4. Atrophic skin deemed clinically prone to blistering
5. Any skin disorder affecting wound healing
6. Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zip Surgical Skin Closure	Zip Surgical Skin Closure	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.
Steel Staples	Steel Staples	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.

Primary Outcome Measures

Name	Time	Method
Incision Appearance / Scar Cosmesis	6-8 weeks post surgery	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.

Secondary Outcome Measures

Name	Time	Method
Range of Motion	2 weeks and 6-8 weeks	Knee Range of Motion for each knee will be measured in degrees
Surgeon Closure Method Satisfaction	6-8 weeks post op	Closure method satisfaction will be collected by a 5 point satisfaction scale: 1. Very Satisfied; 2. Satisfied; 3. Neither; 4. Dissatisfied; 5. Very Dissatisfied A lower score means more satisfaction with the closure method.
Patient Pain - Incisional and General	Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit)	Pain levels will be collected using a 10 point VAS scale.
Surgeon and Patient Scar Satisfaction	6 to 8 wk follow up visit	Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale: Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied

Trial Locations

Locations (1)

Shelbourne Knee Center; 🇺🇸 Indianapolis, Indiana, United States