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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
The Subject's laceration will be closed with sutures per regular institutional policies and procedures.
CHOC Children's
Orange, California, United States
RECRUITINGInvestigator'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.
Time frame: 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.
Time frame: During wound-closure procedure
Total Procedure Time
The investigator or designee will record the total procedure time from the initiation of anesthesia (if used) to completion of closure of the laceration.
Time frame: During wound-closure procedure
Wound Closure Time
The investigator or designee will record the time of the wound closure portion of the procedure measured from initiation of first suture or microMend application to completion of the closure.
Time frame: During wound-closure procedure
Subject assessment of level of pain during wound closure procedure
The Visual Analogue Pain Scale (VAS) is used to measure endpoints on a scale of 0 to 10, with 0 and 10 representing both extremes. To perform the evaluation, the Subject is asked to place a mark on a straight line that has a 0 on the left end and a 10 on the right end of the line. A score of 0 will indicate no pain, while a score of 10 indicates the worst pain imaginable.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
The provider will compare wound closure results between microMend and sutures at the first return clinic visit.
Time frame: 1 month after wound-closure procedure
Subject assessment of level of stress during wound closure procedure
The VAS Score is used to measure endpoints on a scale of 0 to 10, with 0 and 10 representing both extremes. To perform the evaluation, the Subject is asked to place a mark on a straight line that has a 0 on the left end and a 10 on the right end of the line. A score of 0 will indicate no stress, while a score of 10 indicates the worst stress imaginable.
Time frame: 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).
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).
The VAS Score is used to measure endpoints on a scale of 0 to 10, with 0 and 10 representing both extremes. To perform the evaluation, the Subject is asked to place a mark on a straight line that has a 0 on the left end and a 10 on the right end of the line. A score of 0 will indicate no pain, while a score of 10 indicates the worst pain imaginable.
Time frame: 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.
Subject assessment of level of stress during removal of wound closure device
The VAS Score is used to measure endpoints on a scale of 0 to 10, with 0 and 10 representing both extremes. To perform the evaluation, the Subject is asked to place a mark on a straight line that has a 0 on the left end and a 10 on the right end of the line. A score of 0 will indicate no stress, while a score of 10 indicates the worst stress imaginable.
Time frame: 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).
Visual Assessment of wound in individual Subjects taken both before and after application of wound closure device
At least two (2) photographs of each wound will be taken before and after application of wound closure device. An Independent Plastic Surgeon will rate wound appearance and cosmetic results on a 0-10 scale, where 10 indicates the best possible appearance and results, while a score of 0 indicates the worst possible results.product.
Time frame: 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.
Visual Assessment of wound in individual Subjects taken both before and after removal of wound closure device
At least two (2) photographs of each wound will be taken before and after application of wound closure device. An Independent Plastic Surgeon will rate wound appearance and cosmetic results on a 0-10 scale, where 10 indicates the best possible appearance and results, while a score of 0 indicates the worst possible results.
Time frame: 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
Visual Assessment of wound after 1 Month
At least two (2) photographs of each wound will be taken 1 month after initial application of the wound closure device. An Independent Plastic Surgeon will rate wound appearance and cosmetic results on a 0-10 scale, where 10 indicates the best possible appearance and results, while a score of 0 indicates the worst possible results.
Time frame: 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.
Visual Assessment of wound after 3 Months
At least two (2) photographs of each wound will be taken 3 months after initial application of the wound closure device. An Independent Plastic Surgeon will rate wound appearance and cosmetic results on a 0-10 scale, where 10 indicates the best possible appearance and results, while a score of 0 indicates the worst possible results.
Time frame: 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.