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Topical Dexamethasone/Diclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue Injuries
Sponsor: Thamar University
Summary
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.
Official title: Clinical Evaluation of a Topical Hydrogel Loaded With Dual Anti-Inflammatory Agents for Postoperative Pain and Swelling Control in Facial Soft Tissue Injuries
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2026-01-01
Completion Date
2027-01-01
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
Poloxmer F-127 Hydrogel with Dexamethasone/Diclofenac
Active topical hydrogel formulation containing dexamethasone and diclofenac for pain and edema control.
Plain Pluronic F-127 Hydrogel Placebo
Blank hydrogel vehicle without active pharmacologic agents.
Locations (1)
Alwehdah University Teaching Hospital
Dhamar, Yemen