A Clinical trial to compare the 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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/001030

Enrollment

180

Registered

2010-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ornidazole 1% And Povidone Iodine 5% FDC Ointment: local application for twice a day for 14 days Control Intervention1: Povidone iodine 5% Ointment and Ornidazole 1% Ointment: local app

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient or a patient?s authorized legal representative who understands the nature of the study and provides written informed consent. 2. Patients of either sex >18 yrs of age. 3. Patients admitted for any general surgery. 4. Patients ready for study procedure and compliance.

Exclusion criteria

Exclusion criteria: 1. Any known hypersensitivity to any of the investigational product 2. Patients suffering from Diabetes Mellitus 3. Pregnant or Lactating patients

Design outcomes

Primary

Measure	Time frame
Wound parameter evaluation (BATES-JENSEN WOUND ASSESSMENT TOOL ) Incidence, type and intensity of adverse effects and any change in laboratory parameters.Timepoint: Baseline and End of trial	—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Bharat Mahajan

bharat.mahajan@jbcpl.com022-30451215

Outcome results