Clinical Trial Comparing Efficacy and Safety of Ornidazole 1% and Povidone Iodine 5% Fixed Dose Combination Ointment with Povidone Iodine 5% Formulation and Ornidazole 1% Formulation for Prevention or Treatment of Surgical Wounds.

ABSTRACT

Aim: This trial is undertaken to evaluate the efficacy and safety of this FDC ointment for post-surgical patient management. This multi-centre, prospective, randomized, comparative, open-labeled, three-arm parallel group study involving 180 patients was conducted in patients with surgical wound. The trial was conducted at 2 centres and had 90 patients completed at each center. Methods: Patients were in randomized in three groups, to receive either the study formulation of Ornidazole 1% - Povidone iodine 5% FDC ointment (Group I ) or Povidone iodine 5% Ointment (Group II) or Ornidazole 1% Ointment (Group III). These ointments were applied for post surgical wound care. Dressing was done twice daily till the discharge of patients (Day 5-7). Patients were asked to use respective ointment for wound dressings after discharge. The patients were assessed for clinical wound improvement by using the Bates Jensen Wound Assessment Tool (BWATS). General and systemic examination was done at every visit of the patient. Results: Reduction in wound size was significant in all three groups from day 1 onwards. In group I exudates amount improved significantly from day 5 as compared to day 3, in Group II and Group III the improvement was from Day 8 onwards as compared to day 5. Peripheral tissue edema and Peripheral Tissue Induration improved in Group I and as compared to baseline. Epithelialization was statistically better in Group I and Group II from day 1 compared to baseline and in Group III it improved from day 5. No adverse event were seen in any of the groups. Conclusion: We concluded that the combination was better as compared to each individual drug in prevention of wound infection and promoting wound healing.