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

Primary Purpose

Laceration, Skin Wound, Wound Heal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
microMend®
Closure with Sutures
Sponsored by
Children's Hospital of Orange County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laceration focused on measuring Laceration, Wounds, Wound dehiscence, Wound healing

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • CHOC Children'sRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Closure with microMend® Arm

Closure with Sutures Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 2, 2020
Last Updated
March 11, 2022
Sponsor
Children's Hospital of Orange County
Collaborators
KitoTech Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04557761
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Orange County
Collaborators
KitoTech Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration, Skin Wound, Wound Heal
Keywords
Laceration, Wounds, Wound dehiscence, Wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Closure with microMend® Arm
Arm Type
Experimental
Arm 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.
Arm Title
Closure with Sutures Arm
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
microMend®
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Closure with Sutures
Intervention Description
The Subject's laceration will be closed with sutures per regular institutional policies and procedures.
Primary Outcome Measure Information:
Title
Investigator's Assessment of Wound Closure Device (Questionnaire)
Description
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
Title
Investigator's Assessment of Wound Closure Device (Survey)
Description
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
Secondary Outcome Measure Information:
Title
Total Procedure Time
Description
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
Title
Wound Closure Time
Description
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
Title
Subject assessment of level of pain during wound closure procedure
Description
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.
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).
Title
Comparison of Provider's rating of wound closure results with microMend to suture
Description
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
Title
Subject assessment of level of stress during wound closure procedure
Description
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).
Title
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).
Description
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.
Title
Subject assessment of level of stress during removal of wound closure device
Description
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).
Title
Visual Assessment of wound in individual Subjects taken both before and after application of wound closure device
Description
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.
Title
Visual Assessment of wound in individual Subjects taken both before and after removal of wound closure device
Description
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
Title
Visual Assessment of wound after 1 Month
Description
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.
Title
Visual Assessment of wound after 3 Months
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theodore W Heyming, MD
Phone
714-543-8911
Email
theyming@choc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kellie Bacon, MPH
Phone
714-509-8971
Email
kellie.bacon@choc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore W Heyming, MD
Organizational Affiliation
CHOC Children's Hospital of Orange County
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHOC Children's
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kellie Bacon, MPH
Phone
714-509-8971
Email
kellie.bacon@choc.org
First Name & Middle Initial & Last Name & Degree
Shelby Shelton, MPH
Phone
714-509-3742
Email
shelby.shelton@choc.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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