Topical Nifedipine for the Treatment of Pressure Ulcer: A Randomized, Placebo-Controlled Clinical Trial.

Abstract

Effect of nifedipine on pressure ulcer (PU) healing has not been evaluated in the human subjects yet. In this study, the effect of topical application of nifedipine 3% ointment on PU healing in critically ill patients was investigated. This was a randomized, double-blind, placebo-controlled clinical. In this study, 200 patients with stage I or II PU according to 2-digit Stirling Pressure Ulcer Severity Scale were randomized to receive topical nifedipine 3% ointment or placebo twice daily for 14 days. Changes in the size and stage of the ulcers were considered as primary outcome of the study. The stage of the ulcers at baseline and on day 7 and day 14 of study was determined by using 2-digit stirling scale. In addition, the surface area of the wounds was estimated by multiplying width by length. In total, 83 patients in each group completed the study. The groups were matched for the baseline stage and size of PUs. Mean decrease in the stage of PU in the nifedipine group was significantly higher than the placebo group on day 7 (-1.71 vs. -0.16, respectively, P < 0.001) and day 14 (-0.78 vs. -0.09, respectively, P < 0.001). Furthermore, the mean decrease in the surface area of PU was significantly higher in the nifedipine group compared with the placebo group on day 7 (-1.44 vs. -0.32, respectively, P < 0.001) and day 14 (-2.51 vs. -0.24, respectively, P < 0.001) of study. Topical application of nifedipine 3% ointment for 14 days significantly improved the healing process of stage I or II PUs in critically ill patients.