SAFETY AND EFFICACY OF TOPICALLY APPLIED MOIST EXPOSED BURN OINTMENT (MEBO) COMPARED TO SILVER SULPHADIAZINE (SSD) PHASE-III CLINICAL STUDY PROTOCOL

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: MEBO (Moist Expose Burn Ointment): Made up of 5 components (Radix Scutellariae 4.50%, Rhizoma Coptidis 4.50%, Cortex Phellodendri 4.50%, Pheritima 1.80%, Pericarpium Papaveris 1.80%, Oleum Sesami 82.90%). Dosage once A Day application for 14 Days Control Intervention1: Silver Sulphadiazine (SSD): Dosage is once A Day application for 14 Days CONDITION: Mild thermal burn injuries PRIMARY OUTCOME: To evaluate the safety of MEBO in comparison with SSD in the patients with mild thermal burn injuries, through the clinical laboratory report, physical examination, the invasive infection rate.‐‐‐‐‐‐Timepoint: 14 Days SECONDARY OUTCOME: To evaluate the efficacy of MEBO in comparision with SSD in the patients with mild thermal burn injuries, through the assessment of analgesic effect, the wound healing time (days), the wound healing rate in 10 days and the wound healing quality‐‐‐‐‐‐Timepoint: 10 Days INCLUSION CRITERIA: 1. Mild thermal origin burns (Superficial II Degree burns and total burn area for all burns on a single patient no greater than 15% of TBSA); 2. Male or female between 13 and 50 years of age; 3. Patient or patient?s legally acceptable representative is willing to provide voluntary informed consent; 4. Capable of understanding and willing to comply with study protocol requirements; 5. Agree to stay in hospital for the first 7 days of treatment; 6. Female of childbearing potential with a negative result from pregnancy test at screening who agrees to use an acceptable birth control method (hormonal or IUD) or abstinence throughout the trial; and 7. Subjects infected with MRSA can be included based on the opinion of the Investigator.
Epistemonikos ID: b585fd52c11c5d6225358e6a6ee0c8e4f06779e2
First added on: Aug 22, 2024