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Safety and efficacy assessment of a Supernatant spray of Lactobacillus bacteria of second degree burn wounds: a randomized clinical trial

Safety and efficacy assessment of a Supernatant spray of Lactobacillus bacteria of second degree burn wounds: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210524051384N9
Enrollment
15
Registered
2023-05-06
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Second degree burn. Burn and corrosion of head, face, and neck

Interventions

Intervention 1: Control group: Patients whose routine burn treatment includes the use of 1% silver sulfadiazine ointment will be prescribed for them. Intervention 2: Intervention group: Probiotic lact

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: A patient with a stable condition does not need resuscitation or hospitalization. Thermal burns with flame or boiling water. Burns less than 24 hours after the burn (less than 10%). The normal average level of hemoglobin. Clean and non-infected wound. The largest wound is selected if there is more than one wound in a person. The area of ??the wound is less than 20% or more than 1% of the body surface. No history of dangerous diseases. Male or female patients between the ages of 18 and 65. The patient should be capable to fill out the informed consent. Body mass index between 18-30 kg/m2.

Exclusion criteria

Exclusion criteria: Having background diseases such as anemia, diabetes, cardiovascular diseases, malignancy, immune system deficiency, and any other background diseases. Lactating and pregnant women. Chemical or electrical burns. A person's desire to withdraw from the study.

Design outcomes

Primary

MeasureTime frame
Evaluation of local outcomes including: burning, itching, stinging, skin swelling, skin sensitivity to touch, skin rash, erythema, and skin atrophy. Timepoint: 1,2,7,14,21,28 days. Method of measurement: Clinical observations and filling the checklist in 6 time points.;Evaluation of systemic outcomes: Cardiovascular complications, blood complications, electrolyte changes, allergic complications, liver and kidney complications. Timepoint: 1,2,7,14,21,28 days. Method of measurement: Clinical observations and filling the checklist in 6 time points.

Secondary

MeasureTime frame
Wound healing rate. Timepoint: 1,2,7,14,21,28 days. Method of measurement: photography.;Hospital stay. Timepoint: At discharge based on day. Method of measurement: based on patient file.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Mobayen

Rasht University of Medical Sciences

Maziar.mobayen@gmail.com+98 13 3336 8540

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026