[Comparative study of the effectiveness two of hyperoxygenated fatty acids in the treatment of grade I ulcers in geriatric hospitalized patients]

Abstract

Objective: To evaluate whether there is equivalence between two treatments for grade I ulcers with a base of hyperoxygenated fatty acids, AGHO and Mepentol: AGHO and phytotherapy.

Method: A randomized, controlled, triple blind clinical trial was conducted with patients admitted at the Elderly Ward at San Carlos Hospital in Madrid between November 2006 and January 2008. There were two treatment groups: Experimental and control. A theoretical limit of 15% was determined between both groups. We took a random sample of patients admitted to the Elderly Ward, which produced a sample of 151 sores. The control group received treatment with Mepentol and the experimental group received AGHO. The assignment to the group was at random. The output variable was healing of erythema within the first 72h. We calculated the absolute difference in the incidence of healing between both treatments with a level of confidence of 95%.

Results: The sample at the end of the study was 148 (72 control and 76 experimental). There was a healing incidence of 55.6% in the control group and 69.7% in the experimental group (p=0.074). The difference in the incidence of healing between both treatments was 14% (95% CI: 29% to -1%). The upper limit of the confidence interval of the difference is outside the margin of equivalence.

Conclusions: We cannot conclude that the treatment with AGHO fatty acids is equivalent to Mepentol treatment. With both treatments the healing is clinically significant.