Topical Dexamethasone/Diclofenac Hydrogel for Postoperative Pain and Swelling in Facial Soft Tissue Injuries
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThamar University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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 .
Trial design
Design model
Parallel
Treatments tested in this trial
Poloxmer F-127 Hydrogel with Dexamethasone/Diclofenac
DrugActive topical hydrogel formulation containing dexamethasone and diclofenac for pain and edema control.
Plain Pluronic F-127 Hydrogel Placebo
Other interventionBlank hydrogel vehicle without active pharmacologic agents.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Pluronic Hydrogel GroupExperimental treatment 1 intervention
Group B: Placebo Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Severit
Assessment of pain intensity using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame
8 hours, 3 days, and 7 days post-treatment.2
Facial Edema
Assessment of facial swelling using the Ristow 5-line anatomic measurement method.
Time frame
Baseline, 8 hours, 3 days, and 7 days post-treatment.Sponsors and contacts
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Source ClinicalTrials.gov