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

Wound Healing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460172
• Other study ID #: 006
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: February 15, 2017

Study information

• Verified date: February 2019
• Source: ZipLine Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Knee Replacement
• Wound Healing

Intervention

Device:
• Zip Surgical Skin Closure
Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
• Steel Staples
Skin closure device for the closure of the skin layer following surgical incision

Locations

Country	Name	City	State
United States	Shelbourne Knee Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
ZipLine Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	Range of Motion	Knee Range of Motion for each knee will be measured in degrees	2 weeks and 6-8 weeks