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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Arshad Mohammed Almansori, BDS
- Telefonnummer: 0771697007
- E-mail: arshadalmansori987@gmail.com
Studiesteder
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Dhamar, Yemen
- Rekruttering
- Alwehdah University Teaching Hospital
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Kontakt:
- Arshad mohammed Almansori, MSc Candidate
- Telefonnummer: 0771697007
- E-mail: arshadalmansori987@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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 .
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Severit
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nashwan Hamid Al-Tairi, Associate Professor, Faculty of Dentistry, Thamar University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Sår og skader
- Kraniocerebralt traume
- Traumer, nervesystemet
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Smerte
- Ansigtsskader
- Organiske kemikalier
- Carboxylsyrer
- Polycykliske forbindelser
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Steroider, fluoreret
- Gravideretrioler
- Syrer, carbocykliske
- Phenylacetater
- Dexamethason
- Diclofenac
Andre undersøgelses-id-numre
- EC/FD/2025/014
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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