ZIPS Study - Zip Incision aPproximation vs. Suture

Completed · Not applicable

Conditions studied: Wound, Cardiac Arrhythmia

In brief

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 incisions or laceration repair. The study will be comparing the Zip Surgical Skin Closure to standard sutures in patients undergoing cardiovascular implantable electronic device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting scar, and overall cosmetic appearance of scar. The study will be following participants for 3 months following CIED procedure.

Key facts

Study ID: NCT02213510
Run by: University of California, San Diego
People needed: 40
Starts: 2014-08-01
Expected to finish: 2015-06-01
Last updated by the study team: 2016-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

UCSD Sulpizio Cardiovascular Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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