A prospective, randomized clinical trial was conducted from March 2020 to December 2021 (Clinical Trials Registration ID: NCT04831112) to compare the effects of dressing with EUSOL or honey for managing NF wounds in the emergency department after approval from Ethics Review Committee (IRB-1491/DUHS/Approval/2020). After giving their informed consent, patients were assigned to one of the two groups via the lottery method in a single-blinded procedure. Investigators were blinded to the procedure. The manuscript follows the CONSORT guidelines for all analyses and the randomized trial reporting specified in advance [8 ].
Inclusion criteria included adults (>18 years) with a diagnosis of NF with the broadest span of wound <20 cm and who underwent surgical debridement followed by dressing were enrolled in the study.
Exclusion criteria included diabetic wounds, traumatic wounds, and patients who expired during the postoperative period.
Intervention
This study included patients with necrotizing soft tissue infection admitted via the emergency department and underwent thorough evaluation, including history, examination, and investigation. Following admission and after the stabilization of vital signs with intravenous fluids and empiric antibiotics, all patients underwent surgical debridement. All patients are given daily routine dressings following debridement. A total of 175 patients enrolled in the study, with 90 in the intervention group (honey) and 85 in the control group (EUSOL). A sample of infected tissue during surgical debridement was taken for pus culture and sensitivity and tissue for histopathology. The wound of all patients healed by secondary intention. The wound was covered with a honey layer of 4 ml per square inch, followed by a dressing covered by Opsite, which was changed every 24 hours. During the dressing change, clearance of slough and appearance of granulation were assessed. Ber Honey (Ziziphus mauritiana) was collected from the district of Tharparkar Pakistan and sterilized before being used for dressing. Gamma radiation is used to sterilize the honey and get rid of the bacterium spores known to reside in raw honey.
Data collection
The dataset includes the baseline demographic factors including age, gender, comorbidities including diabetes mellitus, ischemic heart disease, chronic liver disease, chronic kidney disease, hypertension, site involved by disease, duration of symptoms, and smoking. The second section contains outcome factors, including days needed for clearance of slough and appearance of granulation tissue, wound healing time, length of hospital stays, and patient satisfaction.
Statistical analysis
SPSS v.25 was used to analyze the data. Statistics were considered significant for a p-value less than 0.05. Categorical data were analyzed as proportions, while continuous parametric data were analyzed as mean with standard deviation. Chi-square was used to measure categorical variables, whereas continuous parametric variables’ variance was assessed using the student’s t-test.
Inclusion criteria included adults (>18 years) with a diagnosis of NF with the broadest span of wound <20 cm and who underwent surgical debridement followed by dressing were enrolled in the study.
Exclusion criteria included diabetic wounds, traumatic wounds, and patients who expired during the postoperative period.
Intervention
This study included patients with necrotizing soft tissue infection admitted via the emergency department and underwent thorough evaluation, including history, examination, and investigation. Following admission and after the stabilization of vital signs with intravenous fluids and empiric antibiotics, all patients underwent surgical debridement. All patients are given daily routine dressings following debridement. A total of 175 patients enrolled in the study, with 90 in the intervention group (honey) and 85 in the control group (EUSOL). A sample of infected tissue during surgical debridement was taken for pus culture and sensitivity and tissue for histopathology. The wound of all patients healed by secondary intention. The wound was covered with a honey layer of 4 ml per square inch, followed by a dressing covered by Opsite, which was changed every 24 hours. During the dressing change, clearance of slough and appearance of granulation were assessed. Ber Honey (Ziziphus mauritiana) was collected from the district of Tharparkar Pakistan and sterilized before being used for dressing. Gamma radiation is used to sterilize the honey and get rid of the bacterium spores known to reside in raw honey.
Data collection
The dataset includes the baseline demographic factors including age, gender, comorbidities including diabetes mellitus, ischemic heart disease, chronic liver disease, chronic kidney disease, hypertension, site involved by disease, duration of symptoms, and smoking. The second section contains outcome factors, including days needed for clearance of slough and appearance of granulation tissue, wound healing time, length of hospital stays, and patient satisfaction.
Statistical analysis
SPSS v.25 was used to analyze the data. Statistics were considered significant for a p-value less than 0.05. Categorical data were analyzed as proportions, while continuous parametric data were analyzed as mean with standard deviation. Chi-square was used to measure categorical variables, whereas continuous parametric variables’ variance was assessed using the student’s t-test.
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