Evaluation of treatment of constipation-induced infection in patients with grade IIb, III skin burn

The aim of this study was to treat constipation in burn patients. Which in the guidelines this process takes place after three to five days, but in this study, one day is considered.

This study was a parallel randomized controlled trial study design. The sample size of the study is 120 patients that will be assigned to intervention and control groups using simple randomization method.

Evaluate and prescribe daily interventions versus three and five days recommended in the guideline, to prevent wound infection caused by constipation. This study will be performed in Motahhari Burn Hospital of Iran University of Medical Sciences. Confirmed patients and hospitalization in burn and intensive care units will be followed for 3 days after receiving Intended interventions, in terms of outcomes. Because the intervention processes in the groups are completely different, the outcome assessor will be blinding of the type of interventions received by the participants.

Patients with grade III and IIb burns, with a burn percentage of 20 to 30, will be selected for the study. In addition, any selected patients with a history of neurological, psychological, diabetes, hypertension, trauma other than burns, and inflammatory bowel disease will be excluded.

Patients in the intervention group are prescribed oral adult Bisacodyl tablet (40 mg), adult Bisacodyl suppository, c-lax tablet, and lactulose during the outcome assessment. Patients in the control group are also given oral Bisacodyl and Bisacodyl suppositories during the outcome evaluation if the patient does not respond, finally, the patient is given normal saline enema on the third day.

Evaluation of constipation status, wound infection, incidence of burn wound infection, incidence of constipation

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.

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.