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Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions

NCT01716013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2017-01-09

Study results available
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Summary

To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in terms of cosmesis (appearance) of the repaired wound when these devices are used for closure of surgical and traumatic wounds .

To demonstrate safety of BondEase™.

Conditions

  • Traumatic Lacerations or Surgical Incisions

Interventions

DEVICE

BondEase

topical skin adhesive

PROCEDURE

CWCD

traditional closure methods of sutures, staples or adhesive strips

Sponsors & Collaborators

  • OptMed, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-01-31
Completion
2014-02-28

Countries

  • United States

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 NCT01716013 on ClinicalTrials.gov