Clinical Research
Removing biofilm and necrosis is essential for healing. A hygroscopic acid containing compound* (TDA) causes desiccation of biofilm and necrosis, with subsequent dissolution and granulation, an essential step in healing by secondary intention.
A clinical evaluation was set up to assess the efficacy of TDA in Wagner III/IV diabetic foot ulcers. Ulcers had to have a culture-confirmed infection with multidrug-resistant Pseudomonas Aeruginosa and had to have been treated with advanced techniques for at least 30 days. Sufficient distal perfusion was a proviso for study participation.
Methods:
After cleansing of the ulcer, it was cultured, TDA was applied for 60 seconds and removed by rinsing with saline. Modern dressings were applied and changed every 7 days. Cultures were taken on post-application-day 14 and 30. The end of study was on day 40. No antibiotic use was allowed during the study.
Results:
20 patients (average age: 74 yrs) with 20 ulcers participated. Average ulcer size was 9.1 cm2. In this cohort, patients had undergone a kidney or pancreas transplant (N=1 for each) and/or revascularization (N=16). 3 Patients had suffered and M.I. and 5 were undergoing hemodialysis. All patients had impaired renal functions. In 6 patients (33%) reinfection occurred. Additional debridement was necessary in 6 patients (33%).
Significant reduction in size of the lesion with complete granulation occurred in 16 (80%) of all patients, with complete reepithelialization of 6 ulcers (33%). 17/20 ulcers (85%) showed improvement or were completely healed, 2/20 (10%) were unchanged and 1/20 (5%) of the ulcers showed deterioration.
Discussion:
Wagner III/VI ulcers are notoriously difficult to heal. As was the case in this patient cohort, patients with these ulcers typically also have several serious comorbidities, and the lesions presented here also were infected with P Aeruginosa. Despite these detrimental factors all but 3/20 ulcers showed significant improvement or complete reepithelialization within 40 days. This indicates that TDA is an efficacious debriding agent, turning a necrosis- and biofilm-covered lesion into one that granulates, a first and essential step for healing by secondary intention.
Trademarked Items: Debrichem, DEBx Medical, Amsterdam, the Netherlands
References: