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

Last updated: March 11, 2022
Sponsor: Children's Hospital of Orange County
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT04557761
1912154
  • Ages 7-17
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects undergoing a laceration repair that would require sutures, staples, or tissueadhesives to close the skin wound.
  • Age between 7 and 17 years old
  • Written informed consent obtained from Subject or Subject's legal representative
  • Ability of Subject to comply with the requirements of the study

Exclusion

Exclusion Criteria:

  • Wound in extensor or flexor surface of knee or elbow
  • Wound on concave areas of the face, such as orbit of the nasal sidewall
  • Wound on fingers or toes
  • Wound under high tension
  • Wound that has a gap of more than 1 cm between the wound edges immediately prior toapplication of microMend devices
  • Facial or body hair that could impede application of the wound closure device
  • Wound with significant tissue injury
  • Wound with active bleeding
  • Wound where adjacent skin is wet
  • Visual evidence of active infection, contaminated or devitalized tissue, or rash atlaceration location
  • Wound that contain a foreign body
  • Wound site that contains tattoo or other identifiable features
  • Subject with keloid(s)
  • Medical disorder that, in the opinion of the Investigator, could have a significanteffect on wound healing
  • Pregnancy
  • Inability of Subject to carry out Subject instructions
  • Subject lacks the capacity to consent
  • Currently using medication that, in the opinion of the Investigator, could have asignificant effect on wound healing
  • Skin disorder, such as psoriasis, or current dermatitis or eczema at wound site
  • History of keloids or scar hypertrophy
  • Known bleeding diathesis
  • Sensitivity or allergy to adhesives or medical tape
  • Active infection in any part of the body
  • Use of sutures or staples to close underlying skin layers
  • Use of staples to close skin wound
  • Use of tissue adhesive or other adhesives directly over the wound

Study Design

Total Participants: 30
Study Start date:
July 13, 2020
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • CHOC Children's

    Orange, California 92868
    United States

    Active - Recruiting

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