Clinical trial NCT04557761: Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
Official title: Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laceration
Skin Wound
Wound Heal
Keywords: Laceration
Wounds
Wound dehiscence
Wound healing
Lead sponsor: Children's Hospital of Orange County
Sponsor class: OTHER
Collaborators: name: KitoTech Medical, Inc.
First posted: 2020-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Investigator's Assessment of Wound Closure Device (Questionnaire)
timeFrame: During wound-closure performance
measure: Investigator's Assessment of Wound Closure Device (Survey)
timeFrame: During wound-closure procedure
Secondary outcomes:
measure: Total Procedure Time
timeFrame: During wound-closure procedure
measure: Wound Closure Time
timeFrame: During wound-closure procedure
measure: Subject assessment of level of pain during wound closure procedure
timeFrame: 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).
measure: Comparison of Provider's rating of wound closure results with microMend to suture
timeFrame: 1 month after wound-closure procedure
measure: Subject assessment of level of stress during wound closure procedure
timeFrame: 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).
measure: 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).
timeFrame: The VAS Score for level of pain during removal of the wound closure device will be collected at the First Return Clinic Visit, Day 5 (5-7) for facial lacerations or Day 8 (7-10) for lacerations elsewhere on the body.
measure: Subject assessment of level of stress during removal of wound closure device
timeFrame: The VAS Score for level of stress during removal of the wound closure device will be collected on the day of the wound closure procedure (Study Day 0).
measure: Visual Assessment of wound in individual Subjects taken both before and after application of wound closure device
timeFrame: Photographs will be taken both before and after application of the wound closure device on the day of the wound closure procedure (Day 0). Photographs will be reviewed by an Independent Plastic Surgeon to assess wound appearance and cosmetic results.
measure: Visual Assessment of wound in individual Subjects taken both before and after removal of wound closure device
timeFrame: Photographs will be taken both before and after removal of the wound closure device on the day of the wound closure procedure (Day 5-7 for facial lacerations, Day 7-10 for lacerations elsewhere on the body). Photographs will be reviewed by an Independent
measure: Visual Assessment of wound after 1 Month
timeFrame: A minimum of two photographs of each wound will be taken 1 month after initial application of the wound closure device. Photographs will be reviewed by an Independent Plastic Surgeon to assess wound appearance and cosmetic results.
measure: Visual Assessment of wound after 3 Months
timeFrame: A minimum of two photographs of each wound will be taken 3 months after initial application of the wound closure device. Photographs will be reviewed by an Independent Plastic Surgeon to assess wound appearance and cosmetic results.
Other outcomes:
Locations:
city: Orange
country: United States
facility: CHOC Children's
state: California
Study officials:
affiliation: CHOC Children's Hospital of Orange County
name: Theodore W Heyming, MD
role: PRINCIPAL_INVESTIGATOR
References: