Tissue Adhesive Versus Sutures in Oral Biopsy Closure (NCT07654166) | Clinical Trial Compass
RecruitingNot Applicable
Tissue Adhesive Versus Sutures in Oral Biopsy Closure
Syria28 participantsStarted 2025-08-12
Plain-language summary
Excisional biopsies are commonly performed in the oral mucosa, and proper wound closure and hemostasis are critical for the success of the surgical procedure. Suturing remains the gold standard for closing surgical incisions; however, it has several drawbacks, including being time-consuming and requiring technical skill for proper placement. In addition, access to posterior areas of the oral cavity can be challenging. Suturing may also cause patient discomfort during needle penetration of tissues and can serve as a potential pathway for microbial contamination. Therefore, this randomized controlled clinical trial aims to evaluate one of the latest tissue adhesives from the cyanoacrylate group (PeriAcryl 90 HV) compared to conventional surgical sutures (Nylon 4-0) for wound closure following oral excisional biopsies. A total of 28 patients with oral fibroma will be randomly assigned to either the tissue adhesive group or the suture group (14 patients per group).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
Patients clinically diagnosed with oral fibroma located on the
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing tissue adhesive to sutures for closing an oral biopsy wound — given that it's measuring wound healing scores and how long the procedure takes, what does my doctor currently think is the better approach for my specific situation, and would it be worth discussing whether this trial might be relevant to my care?
2Since this trial is listed as 'Phase NA,' which often means it's a procedural or device comparison rather than a drug trial, what does my doctor know about the current evidence for tissue adhesive versus sutures in mouth biopsies, and are there any known risks with either closure method I should understand before agreeing to a biopsy?
3The trial measures something called an Early Wound Healing Score — can my doctor explain what that means in practical terms, like what a poorly healing biopsy wound looks like and what symptoms I should watch for after the procedure regardless of which closure method is used?
4If I were to take part in this trial, would I have any say in which closure method I receive, or would it be randomly assigned — and could that affect my recovery or my ability to eat, drink, or speak normally in the days after the biopsy?
5Before considering a trial like this, should I ask about getting the biopsy done first as standard care, and would participating in this study change anything about the diagnosis process or delay finding out my results?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early Wound Healing Score (EHS)
Timeframe: Assessed at day 7 and day 14 postoperatively.
2
Operative time (minutes)
Timeframe: Measured intraoperatively using a stopwatch.