Overview

The recruitment status of this trial is unknown because the information has not been verified recently.

Condition arthroplasty, replacement, knee
Treatments zip surgical skin closure, steel staples
Phase phase 4
Sponsor ZipLine Medical Inc.
Start date September 2014
End date September 2014
Trial size 0 participants
Trial identifier NCT02255877, 005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples
zip surgical skin closure Zip 16
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.
(Active Comparator)
Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure
zip surgical skin closure Zip 16
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.

Primary Outcomes

Measure
Effectiveness Outcome - Wound Healing
time frame: 6 weeks post surgery

Secondary Outcomes

Measure
Surgeon Satisfaction with the Closure Method
time frame: At Discharge, 1-3 days post surgery
Patient Pain
time frame: Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)
Patient Satisfaction of Scars
time frame: At 6 week Follow up (exit) visit

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by ZipLine Medical Inc..