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

NCT02460172 | Completed Results

• 1 other identifier: 006
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthroplasty, Knee Replacement; Wound Healing

Keywords

bi lateral; knee surgery; arthroplasty; orthopedics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Surgeon Closure Method Satisfaction

  6-8 weeks post op

• Patient Pain - Incisional and General

  Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit)

• Surgeon and Patient Scar Satisfaction

  6 to 8 wk follow up visit

• Range of Motion

  2 weeks and 6-8 weeks

Study Arms (2)

Zip Surgical Skin Closure

ACTIVE COMPARATOR

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.

Device: Zip Surgical Skin Closure

Steel Staples

ACTIVE COMPARATOR

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.

Device: Steel Staples

Interventions

Zip Surgical Skin Closure DEVICE

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

Also known as: Zip16, Zip 8i

Zip Surgical Skin Closure

Steel Staples DEVICE

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

Also known as: Conventional staples

Steel Staples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ZipLine Medical Inc.: lead

Study Sites (1)

Shelbourne Knee Center

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: Wendy Winters, Clinical Project Manager
• Organization: ZipLine Medical

wwinters0@gmail.com

408-506-1866

Study Officials

• Rodney Benner, MD

  Study Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 2, 2015
• Study Start: May 1, 2015
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: March 5, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)