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Evaluation of microMend Device to Close Lacerations

NCT03830515 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-02-05

No results posted yet for this study

Summary

In this study, total of 20 subjects will have lacerations will be closed with microMend, which is an FDA-listed wound closure product. microMend is a wound closure device that is the size and shape of a butterfly bandage and incorporates tiny Microstaples into an adhesive backing. Assessments by practitioners and Subjects of microMend will be made at Days 0 10, and 3 months using a combination of questionnaires and photographs.

Conditions

  • Lacerations
  • Wounds

Interventions

DEVICE

microMend

Wound closure product consisting of tan array of tiny metal Microstaples affixed to adhesive backing. The device is the size and shape of a butterfly closure and intended for closure of skin wounds.

Sponsors & Collaborators

  • Brown University

    collaborator OTHER

  • KitoTech Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Francesca Beaudoin, MD, PhD · Department of Emergency Medicine, Walpert School of Medicine, Brown University

  • Gregory Jay, MD, PhD · Department of Emergency Medicine, Walpert School of Medicine, Brown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2019-10-31
Completion
2019-12-31
FDA Device
Yes

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 NCT03830515 on ClinicalTrials.gov