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Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
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
No Placebo-Only Group
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Investigator's Assessment of Wound Closure Device (Questionnaire)
Investigator's Assessment of Wound Closure Device (Survey)
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
34 Previous Clinical Trials
5,247 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