Comparison of Tissue Adhesive and Surgical Sutures for Wound Closure After Oral Excisional Biopsies: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Tissue adhesive(PeriAcryl90 HV)
Tissue adhesive (PeriAcryl 90 HV) will be applied directly to the wound surface after excisional biopsy.
干预措施: Tissue adhesive (PeriAcryl 90 HV) (Device)
Surgical sutures(Nylon 4-0)
Surgical suture (Nylon 4-0) will be used to close the wound with interrupted stitches.
干预措施: Surgical suture (Nylon 4-0) (Device)
研究者
Omar Hamadah
Professor of oral medicine
Damascus University