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Completed

NCT Number: NCT02460172

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

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

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Key information

Conditions

Arthroplasty, Knee Replacement Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shelbourne Knee Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Zip Surgical Skin Closure

Device

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

Other names: Zip16, Zip 8i

Steel Staples

Device

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

Other names: Conventional staples

Primary outcomes

  1. Incision Appearance / Scar Cosmesis

    Time frame: 6-8 weeks post surgery

    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.

Secondary outcomes

  1. Surgeon Closure Method Satisfaction

    Time frame: 6-8 weeks post op

    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.

  2. Patient Pain - Incisional and General

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

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

  3. Surgeon and Patient Scar Satisfaction

    Time frame: 6 to 8 wk follow up visit

    Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale:

    Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied

  4. Range of Motion

    Time frame: 2 weeks and 6-8 weeks

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

Sponsors and collaborators

Lead sponsor

ZipLine Medical Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2015
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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