STUDY DESIGN: Prospective, randomized, double-blind clinical trial. OBJECTIVES: To evaluate the efficacy of topical phenytoin solution in treating pressure ulcers among patients with spinal cord disorders and to evaluate the systemic absorption of topical phenytoin. SETTING: Physical Medicine and Rehabilitation Unit, Christian Medical College, Vellore, India. METHODS:Twenty-eight patients with stage 2 pressure ulcers were randomized to receive either phenytoin solution (5 mg/ml) or normal saline dressing on their ulcers once daily for 15 days. Efficacy of the treatment was determined by assessing the reduction in Pressure Ulcer Scores for Healing (PUSH 3.0), ulcer volume and ulcer size as on day 16. Serum phenytoin concentrations were estimated to determine the systemic absorption of topical phenytoin. RESULTS: Statistically insignificant but marginally higher reduction in PUSH 3.0 scores and ulcer size were seen with topical phenytoin treatment. Systemic absorption of topical phenytoin was negligible. No adverse drug events were detected during the study. CONCLUSIONS:Phenytoin solution is a safe topical agent that accelerates healing of pressure ulcers. However, its efficacy is only slightly more than normal saline treatment.
RCT Entities:
STUDY DESIGN: Prospective, randomized, double-blind clinical trial. OBJECTIVES: To evaluate the efficacy of topical phenytoin solution in treating pressure ulcers among patients with spinal cord disorders and to evaluate the systemic absorption of topical phenytoin. SETTING: Physical Medicine and Rehabilitation Unit, Christian Medical College, Vellore, India. METHODS: Twenty-eight patients with stage 2 pressure ulcers were randomized to receive either phenytoin solution (5 mg/ml) or normal saline dressing on their ulcers once daily for 15 days. Efficacy of the treatment was determined by assessing the reduction in Pressure Ulcer Scores for Healing (PUSH 3.0), ulcer volume and ulcer size as on day 16. Serum phenytoin concentrations were estimated to determine the systemic absorption of topical phenytoin. RESULTS: Statistically insignificant but marginally higher reduction in PUSH 3.0 scores and ulcer size were seen with topical phenytoin treatment. Systemic absorption of topical phenytoin was negligible. No adverse drug events were detected during the study. CONCLUSIONS:Phenytoin solution is a safe topical agent that accelerates healing of pressure ulcers. However, its efficacy is only slightly more than normal saline treatment.