Topical Dexamethasone/Diclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue Injuries
Clinical Evaluation of a Topical Hydrogel Loaded With Dual Anti-Inflammatory Agents for Postoperative Pain and Swelling Control in Facial Soft Tissue Injuries
This randomized, controlled clinical trial will evaluate the clinical effects of a topical thermoresponsive hydrogel containing dexamethasone sodium phosphate and diclofenac sodium on postoperative pain and facial swelling in patients undergoing extraoral maxillofacial surgical procedures or primary closure of clean facial soft tissue wounds. Participants will be stratified according to fracture status and randomly assigned to receive either the active hydrogel or an identical placebo hydrogel. Pain, facial swelling, wound healing, adverse events, patient satisfaction, and rescue analgesic consumption will be evaluated during the postoperative period.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Arshad Mohammed Almansori, BDS
- 电话号码：0771697007
- 邮箱：arshadalmansori987@gmail.com
学习地点
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Dhamar、也门
- 招聘中
- Alwehdah University Teaching Hospital
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接触：
- Arshad mohammed Almansori, MSc Candidate
- 电话号码：0771697007
- 邮箱：arshadalmansori987@gmail.com
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion and Exclusion Criteria Inclusion Criteria
- Patients undergoing oral and maxillofacial fracture surgeries involving clean surgical incisions .
- Patients presenting with clean oral and maxillofacial soft tissue injuries due to trauma, suitable for primary closure
- ASA class I-II .
- Willing to comply with postoperative follow-up and consent procedures .
Exclusion Criteria
- Patients with infected, contaminated, or extensive avulsive wounds .
- Wounds requiring secondary healing or grafting .
- Patients with systemic conditions affecting healing (e.g., diabetes, immunosuppression) .
- Patients with known allergy to DEX or DIC .
- Pregnant or lactating females .
- Patients with chronic steroid or NSAID use .
- Active infections at the surgical site .
学习计划
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 |
|---|---|
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实验性的：Pluronic Hydrogel Group
Topical application of Pluronic F-127 hydrogel loaded with dexamethasone and diclofenac on facial soft tissue wounds. |
Active topical hydrogel formulation containing dexamethasone and diclofenac for pain and edema control. |
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有源比较器：Placebo Control Group
Topical application of plain Pluronic F-127 hydrogel base without active ingredients (dexamethasone or diclofenac). |
Blank hydrogel vehicle without active pharmacologic agents. |
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 |
|---|---|---|
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Postoperative Pain Severit
大体时间：8 hours, 3 days, and 7 days post-treatment.
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Assessment of pain intensity using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). |
8 hours, 3 days, and 7 days post-treatment.
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Facial Edema
大体时间：Baseline, 8 hours, 3 days, and 7 days post-treatment.
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Assessment of facial swelling using the Ristow 5-line anatomic measurement method. |
Baseline, 8 hours, 3 days, and 7 days post-treatment.
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合作者和调查者
调查人员
- 首席研究员：Nashwan Hamid Al-Tairi, Associate Professor、Faculty of Dentistry, Thamar University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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