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Topical phenytoin solution for treating pressure ulcers: a prospective, randomized, double-blind clinical trial
P K Subbanna1, F X Margaret Shanti, J George
1Department of Pharmacology & Clinical Pharmacology, Christian Medical College, Affiliated to The Tamil Nadu Dr MGR Medical University - Chennai, Vellore, Tamil Nadu, India.
Topical phenytoin solution demonstrated negligible systemic absorption and was safe for treating pressure ulcers in spinal cord injury patients. While it showed a marginal benefit over normal saline, further research is needed to confirm its efficacy.
Area of Science:
- Dermatology
- Pharmacology
- Rehabilitation Medicine
Background:
- Pressure ulcers are a significant complication for patients with spinal cord disorders.
- Effective topical treatments are crucial for managing these debilitating wounds.
- Phenytoin, an anticonvulsant, has shown potential in wound healing.
Purpose of the Study:
- To assess the efficacy of topical phenytoin solution in healing pressure ulcers.
- To determine the systemic absorption of topical phenytoin in patients with spinal cord disorders.
- To evaluate the safety profile of topical phenytoin for pressure ulcer treatment.
Main Methods:
- A prospective, randomized, double-blind clinical trial was conducted.
- 28 patients with stage 2 pressure ulcers received either phenytoin solution or normal saline dressing daily for 15 days.
- Efficacy was measured by Pressure Ulcer Scores for Healing (PUSH 3.0), ulcer volume, and size. Serum phenytoin levels were monitored.
Main Results:
- Topical phenytoin showed a marginally greater reduction in PUSH 3.0 scores and ulcer size compared to normal saline, though not statistically significant.
- Systemic absorption of topical phenytoin was negligible.
- No adverse drug events were observed during the study period.
Conclusions:
- Topical phenytoin solution is a safe agent for treating pressure ulcers.
- The solution demonstrated a slight acceleration in pressure ulcer healing compared to normal saline.
- Further investigation is warranted to fully establish the clinical efficacy of topical phenytoin for pressure ulcer management.
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