Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 10:48 AM
Study NCT ID:
NCT04557761
Status:
UNKNOWN
Last Update Posted:
2022-03-28
First Post:
2020-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
Sponsor:
Children's Hospital of Orange County
Organization:
Study Overview
Official Title:
Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Lacerations are typically closed with sutures, staples, tissue adhesives, or bandages. These methods come with several limitations, however. Sutures and staples can be painful, cause inflammation that can lead to scarring, and require return clinic visits for their removal. Tissue adhesives cannot be used to close wounds under tension, can be associated with inflammation, and carry a risk of wound dehiscence. Bandages are also only useful for closing superficial wounds under low tension. Therefore, there is a need for improved products to close wounds associated with laceration repair.
The current study will use a prospective randomized controlled design to compare the use of sutures to microMend® to treat lacerations among children 7-17 years. Performance of sutures and microMend® will be assessed by investigators, providers and subjects. Participants will be randomized 1:1 between closure of lacerations with microMend® or sutures. Results from this study will help gather further information on the use of microMend® to close wounds in the pediatric population.
The current study will use a prospective randomized controlled design to compare the use of sutures to microMend® to treat lacerations among children 7-17 years. Performance of sutures and microMend® will be assessed by investigators, providers and subjects. Participants will be randomized 1:1 between closure of lacerations with microMend® or sutures. Results from this study will help gather further information on the use of microMend® to close wounds in the pediatric population.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: