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

NCT04557761 | Unknown FDA Device

• 1 other identifier: 1912154
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Laceration; Wounds; Wound dehiscence; Wound healing

Outcome Measures

Primary Outcomes (2)

• Investigator's Assessment of Wound Closure Device (Questionnaire)

  The investigator will complete a questionnaire about the wound. The questionnaire will capture information about the wound including the cause of laceration, approximate length of the wound, and whether subcutaneous sutures were used prior to application of micro Mend or sutures. The questionnaire will also indicate whether local anesthesia was used.

  During wound-closure performance

• Investigator's Assessment of Wound Closure Device (Survey)

  The investigator will rate the performance of the wound closure device using a survey to rate the ease of use, speed of use, wound appearance, and provide an overall rating for the experience of using the wound closure device. Each parameter will be determined to be Excellent, Good, Fair or Poor, which correspond to numerical ratings of 4, 3, 2, and 1, respectively.

  During wound-closure procedure

Secondary Outcomes (11)

• Total Procedure Time

  During wound-closure procedure

• Wound Closure Time

  During wound-closure procedure

• Subject assessment of level of pain during wound closure procedure

  The VAS Score for level of pain during the wound closure procedure will be collected on the day of the wound closure procedure (Study Day 0).

• Comparison of Provider's rating of wound closure results with microMend to suture

  1 month after wound-closure procedure

• Subject assessment of level of stress during wound closure procedure

  The VAS Score for level of stress during the wound closure procedure will be collected on the day of the wound closure procedure (Study Day 0).

Study Arms (2)

Closure with microMend® Arm

EXPERIMENTAL

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

Device: microMend®

Closure with Sutures Arm

ACTIVE COMPARATOR

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.

Device: Closure with Sutures

Interventions

microMend® 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 microMend® Arm

Closure with Sutures DEVICE

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

Closure with Sutures Arm

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Orange County: lead
• KitoTech Medical, Inc.: collaborator

Study Sites (1)

CHOC Children's

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Conditions

Lacerations; Wounds and Injuries

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Theodore W Heyming, MD

  CHOC Children's Hospital of Orange County

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theodore W Heyming, MD

CONTACT

714-543-8911; theyming@choc.org

Kellie Bacon, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 22, 2020
• Study Start: July 13, 2020
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)