CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Zip Surgical Skin Closure Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02213510
NCT02213510N/ACompleted
CompareCT.gov

A Prospective, Non-blinded, Randomized Controlled Post-market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device Versus Conventional Sutures for Skin Closure in Subjects Who Undergo a CIED Procedure.

University of California, San Diego·interventional·Posted Aug 11, 2014·Updated May 30, 2016

In Brief

A clinical study evaluating Zip Surgical Skin Closure Device and Standard Suture Closure for Wound and Cardiac Arrhythmia. Completed, enrolled 40 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWound, Cardiac Arrhythmia
CountriesUnited States
CollaboratorsZipLine Medical Inc.

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 11, 2014
Enrollment StartAug 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.9 years ago

Interventions

Zip Surgical Skin Closure Devicedevice

The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.

Standard Suture Closuredevice

The surgeon will perform standard suture closure for the skin layer following CIED procedure.