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WithdrawnNCT03201536ZIPS3Updated Jun 28, 2017

ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

An interventional study of conventional Suture and Zip3 in Wounds and Injuries, sponsored by ZipLine Medical Inc.. Withdrawn at 3 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-28.

Sponsored by ZipLine Medical Inc. · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Lack of enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Wounds and Injuries

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Keywords

  • ZipLine3 device vs. conventional sutures
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

Browse Wounds and Injuries studies →

Lead sponsor

ZipLine Medical Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    sutures

    zipLine3 device verses conventional sutures

    Device: conventional Suture

  • Active comparator
    Zip3 Device

    Device: Zip3

Interventions

  • Deviceconventional Suture

    Sutures

    Also known as: stitches,PeriStrips

  • DeviceZip3

    wound closure device

06

What researchers measure

Primary outcomes

  1. Wound healing

    Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale

    Time frame: 3-month

Secondary outcomes

  1. time of procedure

    Time it takes to use device

    Time frame: immediately

07

Study locations

3 sites
  • Palo Alto Medical Foundation
    Palo Alto, California 94301, United States
  • Plastic Surgery Institute of Northern California
    San Francisco, California 94114, United States
  • California Pacific Medical Center
    San Francisco, California 94115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03201536
Lead sponsor
ZipLine Medical Inc.
Responsible party
Sponsor
First posted
Jun 28, 2017
Start date
Oct 2012
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Jun 28, 2017

Study contacts

Brian M Parret, MD
principal investigator · Plastic Surgery Institute of Northern California
Landon Clark, MD,MPH
principal investigator · Palo Alto Medical Foundation
Stanley P Leong, MD,FACS
principal investigator · California Pacific Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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