Tissue Adhesive Versus Sutures in Oral Biopsy Closure
2026年6月16日 更新者：Omar Hamadah、Damascus University
Comparison of Tissue Adhesive and Surgical Sutures for Wound Closure After Oral Excisional Biopsies: A Randomized Controlled Clinical 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).
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
28
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Nour J Ibrahim, DDS _ MSc student
- 电话号码：+963959800513
- 邮箱：nouribrahim649@gmail.com
研究联系人备份
- 姓名：Omar H Hamadah, Professor
- 电话号码：+963940705554
- 邮箱：Omar.hamadah@gmail.com
学习地点
-
-
Mazzh
-
Damascus、Mazzh、叙利亚
- 招聘中
- Damascus University ,Department of Oral Medicine, Faculty of Dentistry
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接触：
- Omar H Hamadah, Professor
- 电话号码：+963940705554
- 邮箱：Omar.hamadah@gmail.com
-
接触：
- Nour J Ibrahim, DDS_ MSc student
- 电话号码：+963959800513
- 邮箱：nouribrahim649@gmail.com
-
副研究员：
- Nour J Ibrahim, DDS _ MSc student
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Tissue adhesive(PeriAcryl90 HV)
Tissue adhesive (PeriAcryl 90 HV) will be applied directly to the wound surface after excisional biopsy.
|
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.
|
|
有源比较器：Surgical sutures(Nylon 4-0)
Surgical suture (Nylon 4-0) will be used to close the wound with interrupted stitches.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Early Wound Healing Score (EHS)
大体时间：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).
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Assessed at day 7 and day 14 postoperatively.
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Operative time (minutes)
大体时间：Measured intraoperatively using a stopwatch.
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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.
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Measured intraoperatively using a stopwatch.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative pain measured by Visual Analogue Scale (VAS)
大体时间：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.
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Measured at 24 hours, 3 days, and 7 days postoperatively.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Marini L, Rojas MA, Sahrmann P, Aghazada R, Pilloni A. Early Wound Healing Score: a system to evaluate the early healing of periodontal soft tissue wounds. J Periodontal Implant Sci. 2018 Oct 24;48(5):274-283. doi: 10.5051/jpis.2018.48.5.274. eCollection 2018 Oct.
- Gogulanathan M, Elavenil P, Gnanam A, Raja VB. Evaluation of fibrin sealant as a wound closure agent in mandibular third molar surgery--a prospective, randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2015 Jul;44(7):871-5. doi: 10.1016/j.ijom.2015.02.001. Epub 2015 Feb 23.
- Medeiros I, Pascoal S, Castro F, Macedo JP, Lopes O, Pereira J. Tissue adhesives for closure of intraoral surgical incisions: A systematic review and meta-analysis. Int Wound J. 2024 Oct;21(10):e70047. doi: 10.1111/iwj.70047.
- Oladega AA, James O, Adeyemo WL. Cyanoacrylate tissue adhesive or silk suture for closure of surgical wound following removal of an impacted mandibular third molar: A randomized controlled study. J Craniomaxillofac Surg. 2019 Jan;47(1):93-98. doi: 10.1016/j.jcms.2018.10.018. Epub 2018 Nov 12.
- Suthar P, Shah S, Waknis P, Limaye G, Saha A, Sathe P. Comparing intra-oral wound healing after alveoloplasty using silk sutures and n-butyl-2-cyanoacrylate. J Korean Assoc Oral Maxillofac Surg. 2020 Feb;46(1):28-35. doi: 10.5125/jkaoms.2020.46.1.28. Epub 2020 Feb 26.
- Rezende ML, Cunha Pde O, Damante CA, Santana AC, Greghi SL, Zangrando MS. Cyanoacrylate Adhesive as an Alternative Tool for Membrane Fixation in Guided Tissue Regeneration. J Contemp Dent Pract. 2015 Jun 1;16(6):512-8. doi: 10.5005/jp-journals-10024-1714.
- Akhter J, Kalita S, Goyal R, Jaiswal P, Ramalingam K, Yadav D. A Comparison Between the Effectiveness of Isoamyl 2-Cyanoacrylate Tissue Adhesive and Silk Sutures in Wound Closure Following Minor Oral Surgical Procedures: A Prospective Clinical Study. Cureus. 2023 Jul 16;15(7):e41973. doi: 10.7759/cureus.41973. eCollection 2023 Jul.
- Ludlow JB, Kutcher MJ, Samuelson A. Intraoral digital imaging documenting recurrent aphthous ulcer healing in 2-octyl cyanoacrylate versus sham-treated lesions. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Apr;89(4):425-31. doi: 10.1016/s1079-2104(00)70123-5.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年8月12日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年6月12日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- DN- 230226-649
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