ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study (ZIPS3)

June 26, 2017 updated by: ZipLine Medical Inc.

ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study

Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate user preferences associated with the ZipLine 3 system versus conventional suture placement.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • San Francisco, California, United States, 94114
        • Plastic Surgery Institute of Northern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients between 18 and 75 years of age

    • In generally good health
    • Willing to be evaluated in 5-14 days and 3-months post op

  2. Patient requiring a non-emergent skin incision or biopsy

    • Maximum excision size 1.5x3.0 cm
    • Requiring 4-0 or smaller suture for closure
    • In area of body trunk or extremities with low mobility and tension

Exclusion Criteria:

  1. Facial Incisions or incisions in high stress or tension areas
  2. Previously diagnosed peripheral vascular disease
  3. Insulin-dependent diabetes mellitus
  4. Known bleeding diathesis
  5. Known personal or family history of keloid formation or scar hypertrophy
  6. Known allergy or hypersensitivity to adhesives
  7. Presently taking steroids, immune stimulants, beta blockers, or anticoagulants
  8. Atrophic skin deemed clinically prone to blistering
  9. Any skin disorder affecting wound healing
  10. Incisions requiring dermal sutures
  11. Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sutures
zipLine3 device verses conventional sutures
Device: conventional Suture
Sutures
Other Names:
  • stitches,PeriStrips
Active Comparator: Zip3 Device
Device: Zip3
wound closure device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing
Time Frame: 3-month
Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale
3-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of procedure
Time Frame: immediately
Time it takes to use device
immediately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZipLine Medical Inc.

Investigators

  • Principal Investigator: Brian M Parret, MD, Plastic Surgery Institute of Northern California
  • Principal Investigator: Landon Clark, MD,MPH, Palo Alto Medical Foundation
  • Principal Investigator: Stanley P Leong, MD,FACS, California Pacific Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

May 21, 2012

First Submitted That Met QC Criteria

June 26, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-002-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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