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.
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Date
2013-07
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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.
Description
Keywords
surgical wound infection, ornidazole 1%, povidone iodine ointment
Citation
Vyas Dipak, Walwaikar P P, Shah Manish, Mahajan Bharat. 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. Indian Medical Gazette. 2013 Jul ; 147 (7): 265-270.