Evaluation of microMend Device to Close Lacerations
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/7/2019 |
| Start Date: | April 20, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Ronald Berenson, MD |
| Email: | rberenson@kitotechmedical.com |
| Phone: | 206-790-1094 |
Evaluation of microMend Device to Close Skin Wounds Associated With Repair of Lacerations
In this study, total of 20 subjects will have lacerations will be closed with microMend,
which is an FDA-listed wound closure product. microMend is a wound closure device that is the
size and shape of a butterfly bandage and incorporates tiny Microstaples into an adhesive
backing. Assessments by practitioners and Subjects of microMend will be made at Days 0 10,
and 3 months using a combination of questionnaires and photographs.
which is an FDA-listed wound closure product. microMend is a wound closure device that is the
size and shape of a butterfly bandage and incorporates tiny Microstaples into an adhesive
backing. Assessments by practitioners and Subjects of microMend will be made at Days 0 10,
and 3 months using a combination of questionnaires and photographs.
This is an open-label, single-arm Phase 2 Study to evaluate closure of skin wounds associated
with laceration repair using microMend devices. A maximum of 20 Subjects will be enrolled in
the Study in order to have 15 Subjects with evaluations at Month 3 after wound closure. The
primary intent is to assess the wound closure results with microMend closure at Month 3 after
the wound closure procedure. Evaluations will also take place at Days 0 and 10 and 1 Month
post-procedure to assess wound closure results. An Independent Plastic Surgeon who is not
closing wounds in the study will assess the efficacy of wound closure at Day 10, Month 1, and
Month 3. Assessment will also be made of the Subject's pain with applying microMend, time of
wound closure, and opinions of the Providers and Subjects about microMend.
Screening data will be reviewed to determine Subject eligibility. Subjects who meet all
inclusion criteria and none of the exclusion criteria will be entered into the Study. The
Provider may elect to close additional wounds in subjects who have more than one wound that
qualifies for the study.
In the Study, eligible Subjects will undergo the laceration repair procedure as is standard
and customary for each Provider except for skin closure will be performed using microMend
devices. If more than one device is needed, the devices are to be applied adjacent to one
another along the entire length of the wound. microMend devices are to be applied immediately
adjacent to one another with no more than 1 mm separating each adjacent device. (Note: Each
device closes 1-1.5 cm of wound length.). In addition, devices should be applied such that
they extend to or beyond the ends of the wound along its length.
A minimum of two (2) photographs will be taken of each wound both before and after the
application of microMend devices on the day of the wound closure procedure (Day 0).
If a wound is under high tension and/or has a maximum gap of more than 1 cm between the wound
edges, it should be closed with subcutaneous sutures before applying microMend devices. If
this is not performed, the wound should not be closed with microMend and the Subject is not
eligible for the study.
Standard surgical staples, sutures, tissue adhesives, SteriStrips or other bandages should
not be used to close any portion of skin wounds closed with microMend devices.
Each wound should be free of significant tissue injury and bleeding, contain no foreign
bodies, and should be clean and completely dry and free of hair before application of
microMend.
No other wound closure products, such as tissue adhesives, bandages such as SteriStrips,
staples, or sutures should be applied to the wound.
Solutions, ointments, creams, and other moist materials should be avoided during the time
period when the microMend remains on the skin except those recommended by the Provider.
After application of the microMend devices, it is recommended that each wound be covered with
a non-stick gauze dressing. (Note: contact of adhesive with microMend devices is strictly
prohibited.) Subject contact with the wound site should be minimized after placement of the
microMend devices and the dressing. All other activities associated with the laceration
repair procedure should follow the standard procedure used by the Provider. The Provider will
fill out a questionnaire about the wound closure procedure. The Subject will rate the level
of pain associated with microMend application.
The microMend devices are to be removed at the return clinic visit on Day 10 (acceptable
range: Days 7-12) by the Provider (Physician, Nurse Practitioner, Physician's Assistant, or
other qualified health care provider). Photographs are to be obtained of each wound both
before and after removal of all microMend devices. A minimum of two (2) photographs will be
taken of each wound both before and after removal of microMend devices. The Subject will fill
out a questionnaire providing an opinion of microMend.
Each Subject is to return to the clinic at one (1) month post-procedure (acceptable range:
Days 25-40) to obtain photographs of each wound. A minimum of two (2) photographs will be
taken at the 1-month clinic visit. Each Subject is to return to the clinic at three (3)
months after wound closure (acceptable range: 11-15 weeks) to obtain photographs of each
wound. A minimum of two (2) photographs will be taken at the 1-month clinic visit.
Photographs obtained on Day 0, Day 10, Month 1, and Month 3 will be assessed for wound
closure results by an Independent Plastic Surgeon, who is not performing laceration repair or
wound closure in the study. The wound closure will be rated as either Satisfactory or
Unsatisfactory. The quality of the wound closure will further be rated as Excellent, Good,
Fair, or Poor. For Subjects that have had more than one wound closed with microMend devices,
each wound is to be assessed separately at Day 0, Day 10, Month 1, and Month 3.
Total duration of Subject participation will be approximately 4 months, including screening,
treatment, and follow-up.
with laceration repair using microMend devices. A maximum of 20 Subjects will be enrolled in
the Study in order to have 15 Subjects with evaluations at Month 3 after wound closure. The
primary intent is to assess the wound closure results with microMend closure at Month 3 after
the wound closure procedure. Evaluations will also take place at Days 0 and 10 and 1 Month
post-procedure to assess wound closure results. An Independent Plastic Surgeon who is not
closing wounds in the study will assess the efficacy of wound closure at Day 10, Month 1, and
Month 3. Assessment will also be made of the Subject's pain with applying microMend, time of
wound closure, and opinions of the Providers and Subjects about microMend.
Screening data will be reviewed to determine Subject eligibility. Subjects who meet all
inclusion criteria and none of the exclusion criteria will be entered into the Study. The
Provider may elect to close additional wounds in subjects who have more than one wound that
qualifies for the study.
In the Study, eligible Subjects will undergo the laceration repair procedure as is standard
and customary for each Provider except for skin closure will be performed using microMend
devices. If more than one device is needed, the devices are to be applied adjacent to one
another along the entire length of the wound. microMend devices are to be applied immediately
adjacent to one another with no more than 1 mm separating each adjacent device. (Note: Each
device closes 1-1.5 cm of wound length.). In addition, devices should be applied such that
they extend to or beyond the ends of the wound along its length.
A minimum of two (2) photographs will be taken of each wound both before and after the
application of microMend devices on the day of the wound closure procedure (Day 0).
If a wound is under high tension and/or has a maximum gap of more than 1 cm between the wound
edges, it should be closed with subcutaneous sutures before applying microMend devices. If
this is not performed, the wound should not be closed with microMend and the Subject is not
eligible for the study.
Standard surgical staples, sutures, tissue adhesives, SteriStrips or other bandages should
not be used to close any portion of skin wounds closed with microMend devices.
Each wound should be free of significant tissue injury and bleeding, contain no foreign
bodies, and should be clean and completely dry and free of hair before application of
microMend.
No other wound closure products, such as tissue adhesives, bandages such as SteriStrips,
staples, or sutures should be applied to the wound.
Solutions, ointments, creams, and other moist materials should be avoided during the time
period when the microMend remains on the skin except those recommended by the Provider.
After application of the microMend devices, it is recommended that each wound be covered with
a non-stick gauze dressing. (Note: contact of adhesive with microMend devices is strictly
prohibited.) Subject contact with the wound site should be minimized after placement of the
microMend devices and the dressing. All other activities associated with the laceration
repair procedure should follow the standard procedure used by the Provider. The Provider will
fill out a questionnaire about the wound closure procedure. The Subject will rate the level
of pain associated with microMend application.
The microMend devices are to be removed at the return clinic visit on Day 10 (acceptable
range: Days 7-12) by the Provider (Physician, Nurse Practitioner, Physician's Assistant, or
other qualified health care provider). Photographs are to be obtained of each wound both
before and after removal of all microMend devices. A minimum of two (2) photographs will be
taken of each wound both before and after removal of microMend devices. The Subject will fill
out a questionnaire providing an opinion of microMend.
Each Subject is to return to the clinic at one (1) month post-procedure (acceptable range:
Days 25-40) to obtain photographs of each wound. A minimum of two (2) photographs will be
taken at the 1-month clinic visit. Each Subject is to return to the clinic at three (3)
months after wound closure (acceptable range: 11-15 weeks) to obtain photographs of each
wound. A minimum of two (2) photographs will be taken at the 1-month clinic visit.
Photographs obtained on Day 0, Day 10, Month 1, and Month 3 will be assessed for wound
closure results by an Independent Plastic Surgeon, who is not performing laceration repair or
wound closure in the study. The wound closure will be rated as either Satisfactory or
Unsatisfactory. The quality of the wound closure will further be rated as Excellent, Good,
Fair, or Poor. For Subjects that have had more than one wound closed with microMend devices,
each wound is to be assessed separately at Day 0, Day 10, Month 1, and Month 3.
Total duration of Subject participation will be approximately 4 months, including screening,
treatment, and follow-up.
Inclusion Criteria
- Subjects undergoing a laceration repair that would require sutures, staples, or tissue
adhesives to close the skin wound
- Age equal to or greater than 18 years old
- Written informed consent obtained from Subject or Subject's legal representative and
ability for Subject to comply with the requirements of the Study
Exclusion Criteria
- Wound on face
- Wound on flexor surfaces such as over joints
- Wound on digits (fingers or toes)
- Wound under high tension, which is not closed with subcutaneous sutures before
application of microMend devices
- Wound that has a gap of more than 1 cm between the wound edges immediately prior to
application of microMend devices
- Wound with jagged or irregular edges
- Wound with significant tissue injury
- 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 Provider, could have a significant effect
on wound healing
- Pregnancy
- Inability of Subject to carry out Subject instructions
- Subject lacks the capacity to consent
- Medication that, in the opinion of the Provider, 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 in addition to microMend to close the outermost skin layer
- Use of tissue adhesive or other adhesives directly over the wound
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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