Evaluation of microMend Device to Close Skin Wounds Associated With Repair of Lacerations

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.