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

NCT ID: NCT04557761

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-13
• Study Completion Date: 2023-06-30

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.

Conditions

Laceration; Skin Wound; Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

microMend®

Intervention Type: DEVICE

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 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.

Group Type: ACTIVE_COMPARATOR

Closure with Sutures

Intervention Type: DEVICE

The Subject's laceration will be closed with sutures per 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.

Intervention Type: DEVICE

Closure with Sutures

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KitoTech Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Children's Hospital of Orange County

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodore W Heyming, MD

Role: PRINCIPAL_INVESTIGATOR

CHOC Children's Hospital of Orange County

Locations

CHOC Children's

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Theodore W Heyming, MD

Role: CONTACT

theyming@choc.org

714-543-8911

Kellie Bacon, MPH

Role: CONTACT

kellie.bacon@choc.org

714-509-8971

Facility Contacts

Kellie Bacon, MPH

Role: primary

kellie.bacon@choc.org

714-509-8971

Shelby Shelton, MPH

Role: backup

shelby.shelton@choc.org

714-509-3742

Other Identifiers

1912154

Identifier Type: -

Identifier Source: org_study_id