Recruiting

microMend® vs. Sutures

Sponsor:

Children's Hospital of Orange County

Code:

NCT04557761

Conditions

Laceration

Skin Wound

Wound Heal

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

microMend®

Closure with Sutures

Study Details

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.

Conditions

Laceration

Skin Wound

Wound Heal

Study ID

NCT04557761

Start date

Jul 13, 2020

Status verified date

Mar, 2022

Completion date

Jun, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects undergoing a laceration repair that would require sutures, staples, or tissue adhesives 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 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 to application 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 at laceration 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 significant effect 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 a significant 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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Closure with microMend® Arm

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

active comparator: Closure with Sutures Arm

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.

Interventions

microMend®

microMend® is a novel wound closure device that consists of arrays of tiny staples, known as Microstaples, which are attached to a backing material that is the size and shape of a butterfly closure. The Microstaples enable secure attachment of the device to the skin, allowing for the safe closure of wounds associated with surgery and traumatic injuries, such as lacerations. microMend is listed with the FDA and is available for sale in the United States.

Closure with Sutures

The Subject's laceration will be closed with sutures per regular institutional policies and procedures.

Primary outcome measure

  • Investigator's Assessment of Wound Closure Device (Questionnaire) [ Time Frame: During wound-closure performance ]
  • Investigator's Assessment of Wound Closure Device (Survey) [ Time Frame: During wound-closure procedure ]

Central Contacts and Locations

Central contacts

Theodore W Heyming, MD

714-543-8911theyming@choc.org

Kellie Bacon, MPH

714-509-8971kellie.bacon@choc.org

Locations

CHOC Children's

Recruiting

Orange, California, United States, 92868

Contacts

Kellie Bacon, MPH

714-509-8971kellie.bacon@choc.org

Shelby Shelton, MPH

714-509-3742shelby.shelton@choc.org

More Information

Sponsor

Children's Hospital of Orange County

Last update posted

Mar 28, 2022

Last verified

Mar, 2022

Keywords

  • Laceration
  • Wounds
  • Wound dehiscence
  • Wound healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Orange County on 2022-03-28.