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

ZipLine Medical Inc.25 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Arthroplasty, Knee Replacement Wound Healing

Interventions

Zip Surgical Skin ClosureDEVICE

Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.

Steel StaplesDEVICE

Skin closure device for the closure of the skin layer following surgical incision

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shelbourne Knee Center

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 6-8 weeks post surgery

Secondary Outcomes

Surgeon Closure Method Satisfaction

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.

Time frame: 6-8 weeks post op

Patient Pain - Incisional and General

Pain levels will be collected using a 10 point VAS scale.

Time frame: 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

Time frame: 6 to 8 wk follow up visit

Range of Motion

Knee Range of Motion for each knee will be measured in degrees

Time frame: 2 weeks and 6-8 weeks

Data from ClinicalTrials.gov

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