Health Condition 1: null- Burn
Conditions
Interventions
Intervention1: Pseudovac Vaccine: A total volume of 3 mL Pseudovac vaccine will be administered in five divided in 10 days
Control Intervention1: standard treatment: standard treatment for burn patien
Sponsors
AllMed International Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female patients aged between 18 to 60 yrs. • Patients with thermal burns caused by flame or hot liquid or steam. • Patients with or without Pseudomonas infections • Patients who are admitted in the hospital within 24 hrs of the burns infliction. • Patients with second and third degree burns covering between 11-60% of the total body surface. • Abbreviated Burn Severity Index (ABSI) score between 4 and 10. • Patients willing to give written, signed or thumb-printed and witnessed informed consent. • Willing to comply with protocol requirements. • Female subjects with child bearing potential are included only if serum- pregnancy test is negative at the time of enrollment and are willing to practice reliable method of contraception during the study period.
Exclusion criteria
Exclusion criteria: • Patients with electrical burns, chemical burns, and radiation burns. • Acute infections complicated with fever. • Patients with facial, genital or perineal burns. • Pregnant women (positive pregnancy test) or nursing mothers. • Serious acute or chronic illness (such as immuno-compromising diseases, life threatening trauma, or neoplastic disease) determined by clinical or physical examination and laboratory screening tests. • Hypersensitivity to any of the substances used in the vaccine or any chemically related substances. • Chronic administration of immune-suppressants or other immune-modifying drugs within six months prior to the first vaccine dose. • Patients whose laboratory test results are out of acceptable limits, performed at the time of screening. • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine or planned use during the study period. • History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. • Burns due to suicide attempt. • Current alcohol or drug abuse. • Family history of immuno-deficiency. • Any other findings that the Investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Pseudovac in reducing the P. aeruginosa infections which would be determined in culture tests a) Burn wound swab culture b) Blood culture c) Urine cultureTimepoint: Burn wound swab will be collected before every dressing replacement. Blood and urine culture would be performed on Day 1 & 30 and when clinically indicated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess the efficacy of Pseudovac in prevention of septicemia and death due to P. aeruginosa infections 2) To compare wound healing time in both groups 3) To assess immunogenicity and safety profile.Timepoint: P. aeruginosa IgG antibodies level in serum will be measured using ELISA on Days 1, 4, 7, 17 and 25 in both the groups. | — |
Countries
India
Contacts
Public ContactDr Manoj Karwa
Outcome results
None listed