RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

Topical Dexamethasone/Diclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue Injuries

Sponsor: Thamar University • ClinicalTrials.gov ID: NCT07853664

Registry updated: 2026-10-02

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Description

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.

Interventions

Poloxmer F-127 Hydrogel with Dexamethasone/Diclofenac (Drug)
Active topical hydrogel formulation containing dexamethasone and diclofenac for pain and edema control.
Plain Pluronic F-127 Hydrogel Placebo (Other)
Blank hydrogel vehicle without active pharmacologic agents.

Eligibility criteria

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 .

Conditions

Facial Injuries Pain Swelling

Locations

Alwehdah University Teaching Hospital — Dhamar, Yemen

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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