Topical phenytoin versus EUSOL in the treatment of non-malignant chronic leg ulcers.

OBJECTIVE

To compare topical diphenylhydantoin (phenytoin) with Edinburgh University solution of lime (EUSOL) in terms of rate of ulcer healing, analgesic and antibacterial properties in non-malignant chronic leg ulcers.

DESIGN

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.