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microMend® for Cuts

N/A

Waitlist Available

Led By Theodore W Heyming, MD

Research Sponsored by Children's Hospital of Orange County

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

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

Cuts
Dermabrasion
Wound Healing

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after wound-closure procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after wound-closure procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after wound-closure procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Investigator's Assessment of Wound Closure Device (Questionnaire)

Investigator's Assessment of Wound Closure Device (Survey)

Secondary outcome measures

Comparison of Provider's rating of wound closure results with microMend to suture

Pain

Subject assessment of level of stress during removal of wound closure device

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Closure with microMend® ArmExperimental Treatment1 Intervention

The microMend® wound closure product will be used to close the Subject's laceration. The wound will be covered with a non-stick dressing.

Group II: Closure with Sutures ArmActive Control1 Intervention

The Subject's laceration will be closed with sutures. The standard method for suture closed wounds will be followed in accordance with regular institutional policies and procedures.

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Who is running the clinical trial?

Children's Hospital of Orange CountyLead Sponsor

32 Previous Clinical Trials

4,904 Total Patients Enrolled

KitoTech Medical, Inc.Industry Sponsor

1 Previous Clinical Trials

30 Total Patients Enrolled

Theodore W Heyming, MDPrincipal InvestigatorCHOC Children's Hospital of Orange County

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate size of this medical trial's cohort?

"That is correct. According to clinicaltrials.gov, this research initiative initiated on July 13th 2020 and was recently updated on March 11th 2022 is still open for enrollment. 30 individuals are sought out of one medical facility."

Answered by AI

Might I be eligible to participate in this clinical trial?

"This medical trial requires a specific class of participants with lacerations and aged between 7 to 17 years old. It is expected that around 30 such individuals will be recruited for this study."

Answered by AI

What is the ultimate objective of this clinical experimentation?

"The clinical trial sponsor, KitoTech Medical Inc., has outlined the primary outcome of this study: Investigator's Assessment of Wound Closure Device (Questionnaire). Additionally, secondary outcomes such as Comparison of Provider's rating of wound closure results with microMend to suture, Subject assessment of level of pain during wound closure procedure using a Visual Analogue Pain Scale from 0-10 and Visual Assessment of wound after 3 Months via photographic evidence by an Independent Plastic Surgeon will be assessed."

Answered by AI

Are there any vacancies remaining in this medical trial?

"This clinical trial is recruiting participants as per the information on clinicaltrials.gov. The first post announcing this study was made on July 13, 2020 and its most recent update occurred on March 11th 2022."

Answered by AI

Are seniors over 75 years of age precluded from participating in this research?

"Patients that meet the requirements of this trial must be between 7 and 17 years old. Clinicialtrials.gov lists 130 clinical trials for minors while 617 are available to elderly patients over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Comparison of microMend® Devices to Sutures in Closing Lacerations in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04557761.