Tissue Adhesive Versus Sutures in Oral Biopsy Closure
ConditionMouth Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDamascus University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Lesion requires excisional biopsy.
Lesion size greater than 3 mm and less than 3 cm in
Disqualifiers
Pregnant or breastfeeding women.
Patients taking anticoagulant medications (blood thinners).
Patients with infectious diseases such as hepatitis, HIV, etc.
Patients taking immunosuppressants.
Trial design
Design model
Parallel
Treatments tested in this trial
Tissue adhesive (PeriAcryl 90 HV)
DeviceAfter excisional biopsy of oral fibroma and achieving hemostasis by applying pressure with saline-soaked gauze, the wound surface will be gently dried. PeriAcryl 90 HV (high viscosity butyl cyanoacrylate) will be applied directly using a pipette to cover the entire wound surface . A second layer will be applied 10-15 seconds after the first layer to ensure adequate thickness and durability. The adhesive will polymerize upon contact with moist tissue within approximately 10-20 seconds.
Surgical suture (Nylon 4-0)
DeviceAfter excisional biopsy of oral fibroma and achieving hemostasis, the wound margins will be approximated using tissue forceps. Interrupted sutures using Nylon 4-0 will be placed to close the wound. Sutures will be removed on day 7 postoperatively.
Treatment groups
28 Participants
are divided into 2 treatment groupsGroup A: Tissue adhesive(PeriAcryl90 HV)Experimental treatment 1 intervention
Group B: Surgical sutures(Nylon 4-0)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Early Wound Healing Score (EHS)
Wound healing will be assessed using the Early Wound Healing Score (EHS), a validated clinical index that evaluates three parameters: clinical signs of re-epithelialization (CSR, scored 0-6), clinical signs of haemostasis (CSH, scored 0-2), and clinical signs of inflammation (CSI, scored 0-2). The total score ranges from 0 (worst healing) to 10 (excellent healing).
Time frame
Assessed at day 7 and day 14 postoperatively.2
Operative time (minutes)
The time measured from the start of wound closure (immediately after excisional biopsy and hemostasis) to the complete wound closure. For the tissue adhesive group, this ends when the second layer polymerizes. For the suture group, this ends after the last interrupted suture is placed.
Time frame
Measured intraoperatively using a stopwatch.Secondary outcomes
1
Postoperative pain measured by Visual Analogue Scale (VAS)
Pain intensity will be assessed using a 10-cm Visual Analogue Scale (VAS), where 0 cm represents "no pain" and 10 cm represents "the worst possible pain". Patients will be asked to mark their pain level on the scale at each time point.
Time frame
Measured at 24 hours, 3 days, and 7 days postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov