Study Stopped
Lack of enrollment
ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study
ZIPS3
ZipLine Incision Approzimation Vs. Suture:Zips3 Physician Preference Study
1 other identifier
interventional
N/A
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2012
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedJune 28, 2017
June 1, 2017
Same day
May 21, 2012
June 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing
Wound healing as judged by the CVAS (Cosmetic Visual Analogue Scale) wound healing scale
3-month
Secondary Outcomes (1)
time of procedure
immediately
Study Arms (2)
sutures
ACTIVE COMPARATORzipLine3 device verses conventional sutures
Zip3 Device
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- Facial Incisions or incisions in high stress or tension areas
- Previously diagnosed peripheral vascular disease
- Insulin-dependent diabetes mellitus
- Known bleeding diathesis
- Known personal or family history of keloid formation or scar hypertrophy
- Known allergy or hypersensitivity to adhesives
- Presently taking steroids, immune stimulants, beta blockers, or anticoagulants
- Atrophic skin deemed clinically prone to blistering
- Any skin disorder affecting wound healing
- Incisions requiring dermal sutures
- Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
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
MeSH Terms
Conditions
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
June 28, 2017
Study Start
October 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
June 28, 2017
Record last verified: 2017-06