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IRCT20210524051384N3 IRCT 2021-10-15 Rasht University of Medical Sciences Evaluation of the effect of Lactocare in the treatment of burns The effect of Lactocare probiotics on the treatment of acute and severe thermal burns 2021-11-22 anticipated 80 Complete https://irct.ir/trial/59263 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Burns. Intervention 1: Intervention group: The probiotic product is two Lactocare capsules daily for intervention group (A). Two oral capsules will be started daily for ten days after the burn and continue until 95% of the burn wound heals. During the treatment process, a nasogastric tube is inserted to feed the patient. The probiotic products will be first dissolved in an appropriate amount of distilled water and then the solution obtained will been given to the patient by the nasogastric tube. For any reason, the patient's feeding method changes to injectable form, the patient will be excluded from the study if we are unable to provide intestinal nutrition to the patient for more than 48 hours. Lactocare probiotic products will be added to the routine treatment of burns for patients in the intervention group and none of the patients included in the study (both intervention group and control group) will be not banned of routine treatment of burn patients. For all patients, the amount of TBSA per day of hospitalization will calculate by using the Wallace scale. In this study, constipation is defined as non-defecation for three consecutive days and diarrhea as soft defecation more than four times a day or defecation of two or more watery stools in 24 hours. Diarrhea that occurs after taking a laxative will not be included in this count. The presence of infection is assessed using clinical evidence (discharge, new erythema, wound odor, unexplained fever, anorexia, or urinary or respiratory symptoms) followed by relevant blood, urine, wound, or sputum tests.The duration of hospitalization is defined as the length of time spent from the day of hospitalization to the day of discharge and is compared by the percentage of burns between groups A and B. Also, the calculation of the duration of burn wound healing is the time elapsed until 95% of the burn surface heals, which is usually 10 days after the last skin graft, and this variable is also compared in terms of the percentage of burns between the two groups. In case of skin graft for patients, the course of changes will be examined under the supervision of a surgeon, and in case of symptoms related to graft loss, the relevant information is recorded in the draft. Laboratory studies including CRP, albumin serum level, IgA immunoglobulin level and blood lymphocyte and neutrophil count are measured through venous blood samples according to the laboratory protocol of Velayat Hospital on the day of hospitalization and on the fourth, seventh and fourteenth days of hospitalization. The contract obtained with the bio-fermentation company (the manufacturer of the probiotic product Lactocare) regarding the cost of providing the same medicine and placebo, the necessary cooperation will be done, and the mentioned contract was entered in the appendices section of the site. Intervention 2: Control group: Placebo product for control group (B) Two oral capsules will be started daily for ten days after the burn and continue until 95% of the burn wound heals. During the treatment process, a nasogastric tube is inserted to feed the patient. The probiotic products will be first dissolved in an appropriate amount of distilled water and then the solution obtained will been given to the patient by the nasogastric tube. For any reason, the patient's feeding method changes to injectable form, the patient will be excluded from the study if we are unable to provide intestinal nutrition to the patient for more than 48 hours. Lactocare probiotic products will be added to the routine treatment of burns for patients in the intervention group and none of the patients included in the study (both intervention group and control group) will be not banned of routine treatment of burn patients. For all patients, the amount of TBSA per day of hospitalization will calculate by using the Wallace scale. In this study, constipation is defined as non-defecation for three consecutive days and diarrhea as soft defecation more than four times a day or defecation of two or more watery stools in 24 hours. Diarrhea that occurs after taking a laxative will not be included in this count. The presence of infection is assessed using clinical evidence (discharge, new erythema, wound odor, unexplained fever, anorexia, or urinary or respiratory symptoms) followed by relevant blood, urine, wound, or sputum tests.The duration of hospitalization is defined as the length of time spent from the day of hospitalization to the day of discharge and is compared by the percentage of burns between groups A and B. Also, the calculation of the duration of burn wound healing is the time elapsed until 95% of the burn surface heals, which is usually 10 days after the last skin graft, and this variable is also compared in terms of the percentage of burns between the two groups. In case of skin graft for patients, the course of changes will be examined under the supervision of a surgeon, and in case of symptoms related to graft loss, the relevant information is recorded in the draft. Laboratory studies including CRP, albumin serum level, IgA immunoglobulin level and blood lymphocyte and neutrophil count are measured through venous blood samples according to the laboratory protocol of Velayat Hospital on the day of hospitalization and on the fourth, seventh and fourteenth days of hospitalization. The contract obtained with the bio-fermentation company (the manufacturer of the probiotic product Lactocare) regarding the cost of providing the same medicine and placebo, the necessary cooperation will be done, and the mentioned contract was entered in the appendices section of the site. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet - the release schedule is still unknown
public Dr.Mohammadreza Mobayen
Namjoo St
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 maziar.mobayen@gmail.com Rasht University of Medical Sciences scientific Dr.Mohammadreza Mobayen
Namjo St,
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 maziar.mobayen@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients 15-89 years aged, within 24 hours after the occurrence of second or third degree burns with TBSA (Total Body Surface Area) between 20-70%, People with thermal burns are not accompanied by other trauma and have the ability to feed by the digestive system 15 years 89 years Both Patients with digestive diseases Immunodeficiency diseases Chronic diseases such as diabetes and sepsis during hospitalization pregnancy and breastfeeding T29.2-T29. Burns of multiple regions, at least one burn of third degree mentioned, Burns of multiple regions, no more than second-degree burns mentioned Treatment - Drugs Placebo Intervention group: The probiotic product is two Lactocare capsules daily for intervention group (A). Two oral capsules will be started daily for ten days after the burn and continue until 95% of the burn wound heals. During the treatment process, a nasogastric tube is inserted to feed the patient. The probiotic products will be first dissolved in an appropriate amount of distilled water and then the solution obtained will been given to the patient by the nasogastric tube. For any reason, the patient's feeding method changes to injectable form, the patient will be excluded from the study if we are unable to provide intestinal nutrition to the patient for more than 48 hours. Lactocare probiotic products will be added to the routine treatment of burns for patients in the intervention group and none of the patients included in the study (both intervention group and control group) will be not banned of routine treatment of burn patients. For all patients, the amount of TBSA per day of hospitalization will calculate by using the Wallace scale. In this study, constipation is defined as non-defecation for three consecutive days and diarrhea as soft defecation more than four times a day or defecation of two or more watery stools in 24 hours. Diarrhea that occurs after taking a laxative will not be included in this count. The presence of infection is assessed using clinical evidence (discharge, new erythema, wound odor, unexplained fever, anorexia, or urinary or respiratory symptoms) followed by relevant blood, urine, wound, or sputum tests.The duration of hospitalization is defined as the length of time spent from the day of hospitalization to the day of discharge and is compared by the percentage of burns between groups A and B. Also, the calculation of the duration of burn wound healing is the time elapsed until 95% of the burn surface heals, which is usually 10 days after the last skin graft, and this variable is also compared in terms of the percentage of burns between the two groups. In case of skin graft for patients, the course of changes will be examined under the supervision of a surgeon, and in case of symptoms related to graft loss, the relevant information is recorded in the draft. Laboratory studies including CRP, albumin serum level, IgA immunoglobulin level and blood lymphocyte and neutrophil count are measured through venous blood samples according to the laboratory protocol of Velayat Hospital on the day of hospitalization and on the fourth, seventh and fourteenth days of hospitalization. The contract obtained with the bio-fermentation company (the manufacturer of the probiotic product Lactocare) regarding the cost of providing the same medicine and placebo, the necessary cooperation will be done, and the mentioned contract was entered in the appendices section of the site. Control group: Placebo product for control group (B) Two oral capsules will be started daily for ten days after the burn and continue until 95% of the burn wound heals. During the treatment process, a nasogastric tube is inserted to feed the patient. The probiotic products will be first dissolved in an appropriate amount of distilled water and then the solution obtained will been given to the patient by the nasogastric tube. For any reason, the patient's feeding method changes to injectable form, the patient will be excluded from the study if we are unable to provide intestinal nutrition to the patient for more than 48 hours. Lactocare probiotic products will be added to the routine treatment of burns for patients in the intervention group and none of the patients included in the study (both intervention group and control group) will be not banned of routine treatment of burn patients. For all patients, the amount of TBSA per day of hospitalization will calculate by using the Wallace scale. In this study, constipation is defined as non-defecation for three consecutive days and diarrhea as soft defecation more than four times a day or defecation of two or more watery stools in 24 hours. Diarrhea that occurs after taking a laxative will not be included in this count. The presence of infection is assessed using clinical evidence (discharge, new erythema, wound odor, unexplained fever, anorexia, or urinary or respiratory symptoms) followed by relevant blood, urine, wound, or sputum tests.The duration of hospitalization is defined as the length of time spent from the day of hospitalization to the day of discharge and is compared by the percentage of burns between groups A and B. Also, the calculation of the duration of burn wound healing is the time elapsed until 95% of the burn surface heals, which is usually 10 days after the last skin graft, and this variable is also compared in terms of the percentage of burns between the two groups. In case of skin graft for patients, the course of changes will be examined under the supervision of a surgeon, and in case of symptoms related to graft loss, the relevant information is recorded in the draft. Laboratory studies including CRP, albumin serum level, IgA immunoglobulin level and blood lymphocyte and neutrophil count are measured through venous blood samples according to the laboratory protocol of Velayat Hospital on the day of hospitalization and on the fourth, seventh and fourteenth days of hospitalization. The contract obtained with the bio-fermentation company (the manufacturer of the probiotic product Lactocare) regarding the cost of providing the same medicine and placebo, the necessary cooperation will be done, and the mentioned contract was entered in the appendices section of the site. Total Body Surface Area. Timepoint: Percentage of burns. Method of measurement: Measurements based on Wallace criteria. Proportion of length of hospital stay to TBSA. Timepoint: Lenght of hospitalization based on patient records and follow-up until the day of discharge to TBSA. Method of measurement: Number. Mortality. Timepoint: Death means the absence of vital signs during the patient's hospitalization. Method of measurement: Dead / Alive. Number of days of antibiotic usage. Timepoint: Lenght of hospitalization based on patient records and follow-up until the day of discharge. Method of measurement: Based on day. Number of days of taking antifungal medicine. Timepoint: Based on the patient's record and follow-up until the day of discharge. Method of measurement: Based on day. Number of days of gastric complications (diarrhea, constipation, vomiting, laxative used). Timepoint: Based on the patient's history and check-up and follow-up until the day of discharge. Method of measurement: Based on day. Study group. Timepoint: Based on random assignment to study groups. Method of measurement: Intervention / Control. Graft loss. Timepoint: Graft loss that is diagnosed under the supervision of a surgeon and due to symptoms such as swelling, redness, infection, etc. Method of measurement: Yes / no. WLOS / TBSA (wound healing duration ratio to TBSA). Timepoint: Based on the expert's observations about the location of the skin wound. Method of measurement: Number. Number of days of infection. Timepoint: Based on evidence and results of blood or urine culture or wound or sputum. Method of measurement: Day. CRP serum levels. Timepoint: Based on laboratory results. Day of hospitalization and the fourth, seventh, fourteenth days of hospitalization. Method of measurement: mg/L. IgA serum levels. Timepoint: Based on laboratory results. Day of hospitalization and the fourth, seventh, fourteenth days of hospitalization. Method of measurement: mg/dL. Blood lymphocyte and neutrophil count. Timepoint: Based on laboratory results. Day of hospitalization and the fourth, seventh, fourteenth days of hospitalization. Method of measurement: cells/mmŪ³. Albumin serum levels. Timepoint: Based on laboratory results. Day of hospitalization and the fourth, seventh, fourteenth days of hospitalization. Method of measurement: gr/dL. Rasht University of Medical Sciences Approved 2021-09-29 Research Ethic Committees of Guilan University of Medical science Guilan University of Medical science Rsht Guilan Iran (Islamic Republic of)