Comparing Tissue Adhesive PeriAcryl 90 HV Versus Nylon 4-0 Sutures for Oral Fibroma Biopsy Wound Closure in Adults

What this Trial Is About

This research aims to compare a new tissue adhesive called PeriAcryl 90 HV with conventional surgical sutures Nylon 4-0 for closing wounds after oral fibroma excisional biopsies. The study focuses on adults aged 18 to 80 with oral fibroma lesions on the lip or cheek that require biopsy. Proper wound closure and healing are critical, and sutures, while common, have drawbacks like patient discomfort and the need for removal, especially in hard-to-reach areas of the mouth. Participants will be randomly assigned to either receive the tissue adhesive, applied directly to the wound surface in two layers after biopsy, or receive traditional sutures with interrupted stitches that will be removed after 7 days. The tissue adhesive polymerizes quickly upon contact with moist tissue and does not require removal. Both treatments will be assessed under controlled conditions during the surgical procedure. During the study, researchers will measure wound healing using the Early Wound Healing Score at 7 and 14 days after surgery, and record the time taken to close the wound. They will also assess postoperative pain at multiple time points up to 7 days using a pain scale. Participants will have regular follow-up visits for these assessments, contributing to a total study duration extending until December 2027.

Tissue Adhesive Versus Sutures in Oral Biopsy Closure