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IRCT20201226049834N1 IRCT 2021-05-01 Iran University of Medical Sciences Evaluation of treatment of constipation induced infection Evaluation of treatment of constipation-induced infection in patients with grade IIb, III skin burn 2021-05-05 anticipated 120 Complete https://irct.ir/trial/53328 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After the participants were selected to study, we will use simple randomization method to assign to the groups for received intervention and placebo. The randomization process will be performed using Random Allocation software, and since this study consists of two groups, the allocation outputs of the participants will be identified by A and B so the assign of each patient in each group is unpredictable to other members of the research team. We will notify for the team manager after selecting each patient and they will send out each patient's intervention type based on the software output. In this process will be informed of the type of intervention of each patient only clinical caregiver in unfavorable clinical conditions of patients, Blinding description: Single blinding was considered for this study. Due to the different process of interventions in the study groups, only the patient outcome assessor will be blinded of the type of patient interventions. 3 Constipation. Intervention 1: Intervention group: Patients in this group will be treated for symptomatic constipation according to the guideline. The procedure is as follows: One adult Bisacodyl tablet (40 mg) is given. If no defecated within six hours, take two more oral tablets, and if not observed within six hours, use an adult Bisacodyl suppository, and if no response after six hours, take two oral c-lax tablets in the same way as when taking Bisacodyl was prescribed and in case of no response to lactulose in the amount of 20 cc and in case of no response in the amount of 50 cc to the patient. Intervention 2: Control group: If the patient does not defecate for more than five days or the patient feels pain and discomfort from not defecating, the patient is first given two Bisacodyl oral tablets. If the previous treatment does not respond, the adult Bisacodyl suppository is given in two stages at 24-hour intervals, and finally the patient is given normal saline enema on the third day. 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 Has not been proposed in the research team
public Aliakbar Jafarian
Mottahari Burns Hospital, Valiasr St
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8877 0031 Jafarian.ak@iums.ac.ir Iran University of Medical Sciences scientific Aliakbar Jafarian
Mottahari Burns Hospital, Valiasr St
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8877 0031 Jafarian.ak@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Grade IIb, III upper-lower limb burns Burn percentage between 20 to 30 20 years 40 years Both History of neurological diseases including dementia, Alzheimer's, Parkinson's History of psychologic illnesses including known and treated depression and anxiety, mania and schizophrenia Any allergies to laxatives or enzymes used History of Inflammatory bowel disease and Irritable bowel syndrome Coma or loss of consciousness Moderate to severe water and electrolyte disturbance Simultaneous presence of other traumas other than burns Perineal or anal burns History of diabetes, hypertension, heart, respiratory, liver and kidney K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: Patients in this group will be treated for symptomatic constipation according to the guideline. The procedure is as follows: One adult Bisacodyl tablet (40 mg) is given. If no defecated within six hours, take two more oral tablets, and if not observed within six hours, use an adult Bisacodyl suppository, and if no response after six hours, take two oral c-lax tablets in the same way as when taking Bisacodyl was prescribed and in case of no response to lactulose in the amount of 20 cc and in case of no response in the amount of 50 cc to the patient. Control group: If the patient does not defecate for more than five days or the patient feels pain and discomfort from not defecating, the patient is first given two Bisacodyl oral tablets. If the previous treatment does not respond, the adult Bisacodyl suppository is given in two stages at 24-hour intervals, and finally the patient is given normal saline enema on the third day. Evaluation of patients' constipation status. Timepoint: Maximum three days and examination every 12 hours from the beginning of the interventions. Method of measurement: Examination and clinical questions. Wound infection caused by constipation. Timepoint: Duration of hospitalization of patients in infectious wards and intensive care. Method of measurement: Clinical examination and laboratory results. Incidence of burn wound infection. Timepoint: Duration of hospitalization of patients in infectious wards and intensive care. Method of measurement: Clinical examination and laboratory results. Incidence of constipation. Timepoint: Duration of hospitalization of patients in infectious wards and intensive care. Method of measurement: Patient records and clinical examinations. Iran University of Medical Sciences Approved 2020-11-11 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)