microMend® for Lacerations

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lacerations+3 More
microMend® - Device
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

This trial will compare the use of microMend, a new laceration repair product, to sutures. microMend is less painful and easier to use than sutures, and this study will help to determine if it is as effective.

Eligible Conditions
  • Lacerations
  • Wound Healing
  • Dermabrasion

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: A minimum of two photographs of each wound will be taken 1 month after initial application of the wound closure device. Photographs will be reviewed by an Independent Plastic Surgeon to assess wound appearance and cosmetic results.

Month 1
Comparison of Provider's rating of wound closure results with microMend to suture
Month 1
Visual Assessment of wound after 1 Month
Month 3
Visual Assessment of wound after 3 Months
During wound-closure performance
Investigator's Assessment of Wound Closure Device (Questionnaire)
During wound-closure procedure
Investigator's Assessment of Wound Closure Device (Survey)
Total Procedure Time
Wound Closure Time
Day 0
Visual Assessment of wound in individual Subjects taken both before and after application of wound closure device
Day 7
Injury wounds
Day 8
The VAS Score for level of stress during the wound closure procedure will be collected on the day of the wound closure procedure (Study Day 0).
Day 0
Pain
Day 0
Subject assessment of level of stress during removal of wound closure device
Day 0
Subject assessment of level of stress during wound closure procedure

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Closure with Sutures Arm
1 of 2
Closure with microMend® Arm
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: microMend® · No Placebo Group · N/A

Closure with microMend® Arm
Device
Experimental Group · 1 Intervention: microMend® · Intervention Types: Device
Closure with Sutures Arm
Device
ActiveComparator Group · 1 Intervention: Closure with Sutures · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: a minimum of two photographs of each wound will be taken 1 month after initial application of the wound closure device. photographs will be reviewed by an independent plastic surgeon to assess wound appearance and cosmetic results.

Who is running the clinical trial?

KitoTech Medical, Inc.Industry Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Lacerations
30 Patients Enrolled for Lacerations
Children's Hospital of Orange CountyLead Sponsor
27 Previous Clinical Trials
4,547 Total Patients Enrolled
2 Trials studying Lacerations
96 Patients Enrolled for Lacerations
Theodore W Heyming, MDPrincipal InvestigatorCHOC Children's Hospital of Orange County

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.