A prospective randomized controlled study.
SETTING: Muhimbili National Hospital surgical wards from August 2000 to September 2001.
PATIENTS: One hundred and two patients with non-malignant chronic
leg ulcers of various aetiologies, 50 in the study (
phenytoin)group and 52 in the control(
EUSOL) group.
INTERVENTIONS: Study group studied by sprinkling
phenytoin powder and the control group with
EUSOL, in both groups the
ulcers were addressed daily and followed up for 28 days or until they epithelialised or were ready for
skin grafting. The data collected included demographic characteristics of patients, aetiology of the
ulcers,
pus discharge, severity of
pain due to the
ulcers, bacterial cultures from
ulcer swabs, rate of reduction in mean
ulcer surface area and outcome of treatment.
RESULTS: The study enrolled 67 male and 35 female patients over a 14 month period (August to September 2001). Fifty patients formed the study group and 52 formed the controls. The age range was 12-56 years; the majority being in the 27-31 year age group. Major causes of chronic
leg ulcers were those infected following
trauma (27.5%), chronic non-specific
inflammations (21.6%) and infected
burn wounds (15.7%). At enrolment, the duration of
ulcers ranged from 3-156 weeks and 3-128 weeks in the
phenytoin and control groups respectively. Overall, there was significant reduction in
pain(p < 0.05) on day seven in the
phenytoin group. Furthermore in patients who presented with severe
pain, there was a significant reduction in
pain in the
phenytoin group on the fourteenth day (p < 0.01). Clearance of
ulcer discharge was also significant in the
phenytoin group on the seventh and fourteenth day of treatment(p < 0.05). The commonest bacteria isolated were pseudomonas aeruginosa (54.9%) and staphylococcus aureus (10.8%). However, bacterial colonization clearance was not statistically significant when the two groups were compared. The rate of formation of healthy granulation tissue was highly significant in the
phenytoin group by the fourteenth and twenty first days of treatment (p < 0.001). The
phenytoin group showed significant reduction in the mean
ulcer surface area on days 7, 14, 21 and 28 (p < 0.05). Chronic
ulcers due to animal
bites healed fastest followed by those due to
trauma.
CONCLUSION:
Phenytoin powder is cheap and easily applied topically on
ulcers, effectively relieves
pain, clears discharge and enhances formation of granulation tissue thereby promoting healing; reducing morbidity and financial burden enabling its use in resource-poor environments.