LacerationNCT04557761
Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
A study testing microMend® and Closure with Sutures in people with Laceration and Skin Wound, run by Children's Hospital of Orange County at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Laceration, Skin Wound, Wound Heal
- What is being tested?
- microMend® and Closure with Sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
CHOC Children's
Orange, California, 92868
Kellie Bacon, MPH, 714-509-8971, kellie.bacon@choc.org
Shelby Shelton, MPH, 714-509-3742, shelby.shelton@choc.org
About this study
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.
Read the 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
- Being tested
- microMend®, Closure with Sutures
- Keywords
- Laceration, Wounds, Wound dehiscence, Wound healing
- Medical subject headings
- Lacerations, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 SuturesDevice
The Subject's laceration will be closed with sutures per regular institutional policies and procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Closure with Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During wound-closure procedure
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start13 Jul 2020
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LacerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Collaborators
- KitoTech Medical, Inc.
- Responsible party
- Sponsor
- Investigators
- Theodore W Heyming, MD, Principal investigator, CHOC Children's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557761
- Sponsor's protocol ID
- 1912154
- Status last verified
- Mar 2022
- First submitted
- 2 Sep 2020
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of microMend® Devices to Sutures in Closing Lacerations in Children
- ClinicalTrials.gov ID
- NCT04557761
- Acronym / sponsor ID
- 1912154
- Conditions
- Laceration, Skin Wound, Wound Heal
- Keywords
- Laceration, Wounds, Wound dehiscence, Wound healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Collaborators
- KitoTech Medical, Inc.
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closure with microMend® Arm | Experimental | Device: microMend®The microMend® wound closure product will be used to close the Subject's laceration. The wound will be covered with a non-stick dressing. |
| Closure with Sutures Arm | Active comparator | Device: Closure with SuturesThe 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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Closure with microMend® Arm |
| Closure with SuturesThe Subject's laceration will be closed with sutures per regular institutional policies and procedures. | Device | Closure with Sutures Arm |
Primary outcome
Investigator's Assessment of Wound Closure Device (Questionnaire)
Time frame: During wound-closure performance
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.
Investigator's Assessment of Wound Closure Device (Survey)
Time frame: During wound-closure procedure
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.
11 secondary outcomes
Total Procedure Time
Time frame: During wound-closure procedure
Wound Closure Time
Time frame: During wound-closure procedure
Subject assessment of level of pain during wound closure procedure
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
Time frame: 1 month after wound-closure procedure
Subject assessment of level of stress during wound closure procedure
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).
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
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
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
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore W Heyming, MD principal investigator
CHOC Children's Hospital of Orange County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microMend® and Closure with Sutures in people with Laceration and Skin Wound, run by Children's Hospital of Orange County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Theodore W Heyming, MD (714-543-8911, theyming@choc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator's Assessment of Wound Closure Device (Questionnaire) (time frame: During wound-closure performance). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.