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Comparison of microMend® Devices to Sutures in Closing Lacerations in Children

NCT04557761 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-28

No results posted yet for this study

Summary

This study will gather information on the use of microMend® to repair lacerations in children and compare the efficacy of microMend® to sutures for laceration repair. microMend® has previously been shown to be less painful and easier to use than sutures, which are the current standard of care for primary wound closures. Results of this research will inform how the treatment of laceration repairs in the pediatric patient population.

Conditions

  • Laceration
  • Skin Wound
  • Wound Heal

Interventions

DEVICE

microMend®

microMend® is a novel wound closure device that consists of arrays of tiny staples, known as Microstaples, which are attached to a backing material that is the size and shape of a butterfly closure. The Microstaples enable secure attachment of the device to the skin, allowing for the safe closure of wounds associated with surgery and traumatic injuries, such as lacerations. microMend is listed with the FDA and is available for sale in the United States.

DEVICE

Closure with Sutures

The Subject's laceration will be closed with sutures per regular institutional policies and procedures.

Sponsors & Collaborators

  • KitoTech Medical, Inc.

    collaborator INDUSTRY

  • Children's Hospital of Orange County

    lead OTHER

Principal Investigators

  • Theodore W Heyming, MD · CHOC Children's Hospital of Orange County

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-12-31
Completion
2023-06-30
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 NCT04557761 on ClinicalTrials.gov