The effect of Lactocare probiotics on the treatment of acute and severe thermal burns

Evaluation of the effect of adding lactocare probiotic products in the treatment of acute and severe thermal burns

A parallel triple-blind clinical trial on 40 patients with intervention and control group. The selection of samples will be done based on the list of version 9 of SAS software and the researcher has no information about the selection sequence of samples and the type of medication used and this is done by the nursing office.

Location: Velayat Hospital(Rasht).The patient, researcher, and evaluator are blinded and samples are randomly selected.

Inclusion criteria: Patients who are 15-89 years, within 24 hours after the occurrence of second or third degree burns with TBSA between 20-70%, people with thermal burns that are not associated with other trauma and the ability to feed by the digestive system.Exclusion criteria: Patients under 15 and over 89, first-degree burns, TBSA under 20 and over 70%, chemical and electrical burns, patients who are unable to feed by the digestive system, patients with gastrointestinal, immunodeficiency, chronic diseases such as diabetes and sepsis during hospitalization, pregnancy and breastfeeding.

A (probiotic group) B (placebo group) Then each of groups A and B will be divided into two subgroups based on TBSA: 1) 20 to 40% 2) 41 to 70%

Proportion of duration of hospitalization and duration of wound healing to TBSA, mortality,number of skin graft surgeries, Graft Loss, gasteric complications, infection, use of antibiotics, antifungal drug, serum CRP level, serum IgA level, blood lymphocyte, neutrophil count and serum albumin level.

The method used to generate a random allocation sequence is based on the list of version 9 of SAS software. In order to randomize the treatment between groups, permutation randomization block method with size 4 and considering TBSA classes between 20-40 and 41-70 will be performed. Considering the time of entry of patients into the study and the label of the drug (A and B, considering that the study is triple blind study, only one of the analysts who is not involved in the study process is aware of the type of treatment assigned). This list is in a sealed envelope in the nursing desk of the maintenance department, and after the study begins, the envelope will be opened and random blocks will be taken out of the envelope separately for the day, and patients will be treated accordingly.

In order to blind the studied samples (patients), placebo, which is completely similar to the probiotic products in terms of shape and inactive compounds, will be given to the patients in the control group. In order to blind the researcher (the treating physician who monitors the treatment process of patients in terms of studied variables such as length of hospital stay, etc.). The selection of samples will be done based on the list of version 9 of SAS software and the researcher has no information about the sequence,the selection of samples and the type of medicine is not consumed and it will be done by the nursing office.