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

Children's Health of Orange County

Status: Unknown

Conditions: Wound Heal; Laceration; Skin Wound

Treatments: Device: Closure with Sutures; Device: microMend®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04557761

1912154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Closure with microMend® Arm

Experimental group

Description:

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

Treatment:

Device: microMend®

Closure with Sutures Arm

Active Comparator group

Description:

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.

Treatment:

Device: Closure with Sutures