ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

NCT ID: NCT03201536

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Wounds and Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sutures

zipLine3 device verses conventional sutures

Group Type ACTIVE_COMPARATOR

conventional Suture

Intervention Type DEVICE

Sutures

Zip3 Device

Group Type ACTIVE_COMPARATOR

Zip3

Intervention Type DEVICE

wound closure device

Interventions

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conventional Suture

Sutures

Intervention Type DEVICE

Zip3

wound closure device

Intervention Type DEVICE

Other Intervention Names

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stitches,PeriStrips

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ZipLine Medical Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian M Parret, MD

Role: PRINCIPAL_INVESTIGATOR

Plastic Surgery Institute of Northern California

Landon Clark, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

Stanley P Leong, MD,FACS

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Locations

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Palo Alto Medical Foundation

Palo Alto, California, United States

Site Status

Plastic Surgery Institute of Northern California

San Francisco, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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100-002-12

Identifier Type: -

Identifier Source: org_study_id

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