Status:
UNKNOWN
Evaluation of microMend Device to Close Lacerations
Lead Sponsor:
KitoTech Medical, Inc.
Collaborating Sponsors:
Brown University
Conditions:
Lacerations
Wounds
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03830515
Start Date
April 20 2018
End Date
December 31 2019
Last Update
February 5 2019
Active Locations (1)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903