Topical Dexa/Diclofenac Gel for Pain and Swelling After Facial Surgery
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
Run by Thamar University · NCT07853664 · Data updated 2026-11-12
A topical gel with dexamethasone and diclofenac is tested to see if it reduces pain and swelling after facial surgeries or clean facial wounds.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Thamar University Academic / other |
| Locations | 1 site (Dhamar) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 20, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07853664 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with clean facial wounds or fractures requiring oral/maxillofacial surgery and who are ASA I-II, willing to follow up after surgery.
✕Probably not a fit
Patients with infected wounds, extensive tissue loss, systemic healing impediments, or allergies to dexamethasone or diclofenac may not benefit and could be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2/3 randomized trial compares a thermoresponsive gel containing dexamethasone sodium phosphate and diclofenac sodium against a placebo gel in patients undergoing facial fracture repair or clean soft tissue closures. Participants are stratified by fracture status and assigned to active or placebo gel applied postoperatively. Outcomes include pain, swelling, wound healing, adverse events, patient satisfaction, and need for extra analgesia during the recovery period. The study aims to determine if the active gel improves postoperative recovery without added safety concerns.
Why it matters
Potential benefit: If successful, patients may experience less pain and swelling after facial procedures and potentially smoother healing.
How similar studies have gone: Related approaches using topical anti-inflammatory gels have shown promise in reducing postoperative pain and swelling in similar settings, but this specific combination and delivery method is under study.
Who can join: the full rules
Show full inclusion / exclusion 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 .
Where it's running
-
Alwehdah University Teaching Hospital
Dhamar, Yemen Recruiting
Study contacts
- Principal investigator: Nashwan Hamid Al-Tairi, Associate Professor — Faculty of Dentistry, Thamar University
- Study coordinator: Arshad Mohammed Almansori, BDS
- Email: arshadalmansori987@gmail.com
- Phone: 0771697007
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.