Mouth Neoplasms
Conditions
Keywords
PeriAcryl 90 HV, Oral fibroma, surgical sutures, excisional biopsy, tissue adhesive
Brief 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).
Detailed description
Appropriate closure of the surgical wound is essential for achieving successful surgical outcomes and optimal wound healing. Although sutures are the most commonly used method for closing wounds in the oral mucosa, they may cause discomfort to patients, particularly in the buccal and labial mucosa. Furthermore, sutures require a second clinical visit for removal. These limitations highlight the clinical need for an alternative to conventional sutures that is easy to apply, does not require removal, and minimizes patient discomfort. This study will compare tissue adhesive (PeriAcryl 90 HV) versus surgical sutures (Nylon 4-0) for wound closure after oral fibroma excision in a randomized controlled trial design.
Interventions
DEVICETissue adhesive (PeriAcryl 90 HV)
After 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.
DEVICESurgical suture (Nylon 4-0)
After 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.
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-Patients clinically diagnosed with oral fibroma located on the labial mucosa (lip) or buccal mucosa (cheek). * Lesion requires excisional biopsy. * Lesion size greater than 3 mm and less than 3 cm in greatest diameter.
Exclusion criteria
* Pregnant or breastfeeding women. * Patients taking anticoagulant medications (blood thinners). * Patients with infectious diseases such as hepatitis, HIV, etc. * Patients taking immunosuppressants. * Patients with uncontrolled diabetes mellitus. * Patients taking medications that affect bleeding and wound healing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Wound Healing Score (EHS) | Assessed at day 7 and day 14 postoperatively. | 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). |
| Operative time (minutes) | Measured intraoperatively using a stopwatch. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain measured by Visual Analogue Scale (VAS) | Measured at 24 hours, 3 days, and 7 days postoperatively. | 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. |
Countries
Syria
Contacts
CONTACTNour J Ibrahim, DDS _ MSc student
CONTACTOmar H Hamadah, Professor
Outcome results
None listed