Surgical Wound Clinical Trial
Official title:
A Multi-Center, Prospective, Open-label, Randomized, Non-inferiority Study of 3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Traumatic Lacerations and Surgical Incisions
The purpose of this study is to generate safety and performance data for 3M™ Topical Tissue Adhesive. Enrolled subjects with qualifying trauma lacerations or surgical incisions will be randomized to receive 3M™ Topical Tissue Adhesive or Histoacryl® Blue Topical Skin Adhesive with follow-up visits at 10 days and 30 days after application of tissue adhesive.
This is a multicenter, prospective, open-label, randomized, non-inferiority study that will include 452 randomized Subjects requiring closure of superficial lacerations, clean traumatic lacerations, low-tension incisions, or surgical incisions from minimally invasive surgeries. The study will enroll Subjects from up to 10 sites in the USA. Subjects will be seen during Screening (no more than 10 days before application of tissue adhesive), on the day in which skin edges of wound(s) are reapproximated and tissue adhesive is applied (Day 0), 10 days after application of the tissue adhesive, and 30 days after application of the tissue adhesive. ;
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