Evaluation of microMend Device to Close Lacerations

Status unconfirmed · Not applicable

Conditions studied: Lacerations, Wounds

In brief

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.

Key facts

Study ID

NCT03830515

Run by

KitoTech Medical, Inc.

People needed

30

Starts

2018-04-20

Expected to finish

2019-12-31

Last updated by the study team

2019-02-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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