ZIPS Study - Zip Incision Approximation vs. STAPLE

Arthroplasty, Replacement, Knee Clinical Trial

— ZIPS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02255877
• Other study ID #: 005
• Status: Withdrawn
• Phase: Phase 4
• First received: September 26, 2014
• Last updated: October 21, 2016
• Start date: September 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: ZipLine Medical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Orthopaedic Research Foundation	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	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	No
Secondary	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	No
Secondary	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.)	No
Secondary	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	No