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.