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Evaluation of Zip Device to Conventional Sutures for Laceration Repair in Pediatrics in an Emergency Department

NCT04122859 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-10-10

No results posted yet for this study

Summary

A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects requiring laceration repair. The investigation population will consist of 30 subjects fulfilling the eligibility criteria for the clinical investigation. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 4 Surgical Skin Closure Device group or the Standard of Care sutures group.

Conditions

  • Laceration of Skin

Interventions

DEVICE

Zip Skin Closure Device

The device is a CE-marked, single use, sterile medical device that is designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic outcome. It adheres to the skin adjacent to an incision or laceration by use of pressure-sensitive skin adhesives.

Sponsors & Collaborators

  • ZipLine Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Uri Balla, MD · Kaplan Medical Center, Eehovot Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-07-01
Completion
2020-07-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04122859 on ClinicalTrials.gov