Topical diphenylhydantoin in the treatment of non-malignant chroonic lower limb ulcers at muhimbili national hospital, Dar es Salaam, Tanzania

Chronic ulcer is a distressing surgical condition causing considerable morbidity. Long-standing ulcers have been implicated to be pre-malignant conditions. Routine use of commonly known antiseptics has been shown to be of limited value though most of these agents work by reducing bacterial wound contamination and super-infection, thereby allowing bodily regeneration mechanisms to take effect. This can be expensive and often associated with prolonged hospital stay. A prospective randomized clinical trial to determine the effectiveness of Diphenylhydantoin powder in the treatment of chronic non-malignant leg ulcers was conducted for a period of 14 months at Muhimbili National Hospital (MNH) on patients admitted to surgical wards. During the study period, August 2000 to September 2001 a total of 102 patients with chronic ulcers were enrolled into the study, of these 50 (49%) constituted the diphenylhydantoin group; while 52 (51%) were treated with a solution of calcium hypochlorite (Eusol) who formed the control group. The effectiveness of the drug in alleviating patients' symptoms and promoting healing was determined clinically and perfoming bacterial culture studies of the ulcer before institution of any therapy and on subsequent days following application of the topical drugs. Parameters for assessment included pain, discharge, formation of healthy granulation tissue, rate of reduction in ulcer surface area and swabs from ulcers for culture and sensitivity was perfomed on three occasions. Data was analysed by manual and Epi Info 6 (2000) computer programme for statistical testing of comparable variables. Male patients accounted for 65.7% while females constituted 34.3%. The mean age in the diphenylhydantoin group was 32.5±14.9 years, while in the control group 34.2±14.7 years. Patients were equally distributed in the treatment groups and there was no statistical difference in age and sex (p>0.05). Prior to commencement of treatment surgical debridement was carried out if required and then all ulcers were washed with normal saline daily followed by application of a thin film of diphenylhydantoin powder and dressed with dry gauze in the study group, while in the control group dressing with a solution of calcium hypochlorite soaked in a gauze was done. Patients were followed up at weekly intervals and the various parameters to assess ulcer healing were recorded. Significant reduction in pain was noted on the 14th (p<0.05) and 21st day (p<0.01), however no significant difference was noted on the 7th and 28th days (p>0.05). Both treatment groups showed progressive negative bacterial culture, no significant difference was noted (p>0.05) Reduction of ulcer pus discharge on 7th ,14th, and 21 st days was noted to be more in the study group as compared to the control. This difference was statistically significant (p<0.05). However, no difference was noted on the 28th day. The rate of formation of healthy granulation tissue was noted to be significantly faster in patients treated with diphenylhydantoin powder than the control group on days 14 and 21 (p<0.001). However no significant difference was noted on the 7th and 28th day (p>0.05). Significant reduction in ulcer surface area was noted throughout the period of assessment in the diphenylhydantoin group when compared to the control group (p<0.05). The healing response in different ulcers was also influenced by the nature of the ulcer and presence of underlying systemic disease. This study has shown the beneficial effects of diphenylhydantoin powder to achieve faster healing of chronic ulcers. The drug when used topically relieves patient symptoms including pain and discharge, causes faster rate in formation of healthy granulation tissue and reduction in the size of ulcers. No adverse effects were noted during the treatment period. The drug is cheap and easy to use and therefore efforts should be made to make it available throughout our resource scarce country. Health workers at all levels should be educated on how to use the drug on patients with chronic ulcers.