Tissue Adhesive Versus Sutures in Oral Biopsy Closure
NCT07654166 · NA · Damascus, Mazzh, Syria
- Condition
- Head and Neck Cancer
- Disease stage
- Stage I-IV
- Phase
- NA
- Study type
- DEVICE
- Intervention
- Tissue adhesive (PeriAcryl 90 HV)
- Age
- 18 Years to 80 Years
- Gender
- All
- Sponsor
- Damascus University
- Research institution
- Damascus University
- Facility
- Damascus University ,Department of Oral Medicine, Faculty of Dentistry
- Research center
- Damascus University ,Department of Oral Medicine, Faculty of Dentistry
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.
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.
Primary outcomes
Early Wound Healing Score (EHS); Operative time (minutes)
Secondary outcomes
Postoperative pain measured by Visual Analogue Scale (VAS)