ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study
NCT ID: NCT03201536
Last Updated: 2017-06-28
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2012-10-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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sutures
zipLine3 device verses conventional sutures
conventional Suture
Sutures
Zip3 Device
Zip3
wound closure device
Interventions
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conventional Suture
Sutures
Zip3
wound closure device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
75 Years
ALL
Yes
Sponsors
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ZipLine Medical Inc.
INDUSTRY
Responsible Party
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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
Plastic Surgery Institute of Northern California
San Francisco, California, United States
California Pacific Medical Center
San Francisco, California, United States
Countries
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Other Identifiers
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100-002-12
Identifier Type: -
Identifier Source: org_study_id
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