A Randomized Controlled Study Comparing the Efficacy of Autologous Smashed Follicular Dermal Graft and Epidermal Cell Suspension versus Normal Saline Dressing in the Treatment of Chronic Nonhealing Trophic Ulcers in Patients with Hansen's Disease.

Abstract

Trophic ulcers remain the most common reason for hospitalization in patients with Hansen's disease. With the introduction of new therapeutic regimens, leprosy can now be cured. However, complications of the disease, such as sensory loss, muscle palsy, absorption of extremities, and recurrent ulcers, still lead to substantial morbidity. The management of patients with trophic ulcers and their consequences is difficult, because it is a recurrent and recalcitrant problem. To evaluate the efficacy of autologous smashed follicular dermal graft and epidermal cell suspension (ECS) in the treatment of chronic nonhealing trophic ulcers in patients with Hansen's disease and to compare its efficacy with normal saline dressing. A total of 46 chronic nonhealing trophic ulcers were randomized into two groups (23 ulcers in each): Ulcers in Group A were treated with autologous smashed follicular dermal graft and ECS; ulcers in Group B were treated with normal saline dressings. Ulcers were assessed based on the rate of ulcer size reduction at every week till 12 weeks and then once a month till the sixth month. All 23 (100%) ulcers in Group A had healed within the study period of six months, whereas only 14 (60.9%) ulcers had healed in Group B. Nine (39.1%) ulcers in Group B had not healed even at the end of six months. All 23 (100%) ulcers in Group A had healed within eight weeks, which was statistically significant, P value <0.05. Trophic ulcers heal faster by autologous smashed follicular dermal graft and ECS, with good results of re-epithelialization of the ulcer bed than by normal saline dressing.