Status:
COMPLETED
ZIPS Study - Zip Incision aPproximation vs. Suture
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
ZipLine Medical Inc.
Conditions:
Wound
Cardiac Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisio...
Detailed Description
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for surgical incisio...
Eligibility Criteria
Inclusion
- Patients 18 years of age and older;
- Patients requiring suture closure for epidermal closure (after placement of cardiac implantable electronic devices; including de novo and re implant generator changes);
- Patients willing and able to complete study protocol
- Life expectancy greater than 1 year
Exclusion
- Known bleeding disorder not caused by medication;
- Known personal or family history of keloid formation or scar hypertrophy;
- Known allergy or hypersensitivity to non-latex skin adhesives;
- Atrophic skin deemed clinically prone to blistering;
- Any skin disorder affecting wound healing;
- Any other condition that in the opinion of the investigator would make a particular subject unsuitable for this study.
- Pregnancy
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02213510
Start Date
August 1 2014
End Date
June 1 2015
Last Update
May 30 2016
Active Locations (1)
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1
UCSD Sulpizio Cardiovascular Center
La Jolla, California, United States, 92037