Data collected from remaining 26 patients (n=13/group) were then used for analysis. Mean age of the patients was 48.7 years (range 22-80 years) with equal number of males and females in each group, 7 and 6 respectively. Diabetes, smoking, and malnutrition status (using significant weight loss > 5% in the last 6 months as an indicator), wound size (small; 1-2cm, large; > 2cm) in control group and Sucralfate group were not statistically difference. Details of wound subsite, final diagnosis and operation were shown in Table2.
Pain VAS score reduction at each time point and interval changes are shown in Figure2. There was a statistically difference in days 3 and 7 (p<0.05). At day3, mean VAS score reduction in Sucralfate group reduced almost half from baseline (44.1%) while in the control group, there was a 13.5% reduction
For the primary outcome, overall patient VAS at day 0 had normal distribution with a mean VAS score of 4.20 and baseline had no statistical difference between the two groups. Number of rescue paracetamol use was 5.25 tablets/patient in Sucralfate group and 6 tablets/patient in control group, which was also not statistically difference.
Morphine injection was not requested in any of the patient groups. There was no dropout of pain VAS data but home records of paracetamol use was missing in some OPD patients (n=7).
For the secondary outcome, wound healing was assessed by wound grade and wound length reduction at day7 and day14 compared to baseline. Incomplete wound assessment data was in some patients were due to transportation issues during COVID-19 pandemic lockdown in Thailand. Data analysis by intention to treat and per protocol were carried out and were found to have the same statistically significance. To minimize randomization bias in the small sample size, wound assessment was done through intention to treat analysis.