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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
Application of investigational topical tissue adhesive to trauma laceration or surgical incision.
Application of control topical tissue adhesive to trauma laceration or surgical incision.
Apposition of Skin Edges
Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive
Time frame: 10 days
Tissue Adhesive Remaining
Percentage (%) of the sum of the subject's wound length(s), in relation to the sum of the original incision/laceration length(s), with tissue adhesive remaining at 10 days after application of tissue adhesive
Time frame: 10 days
Apposition of Skin Edges
Percentage of subjects with wounds with 100% apposition of skin edges at 30 days after application of tissue adhesive
Time frame: 30 days
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