Shadi Farsaei1, Hossein Khalili, Effat Sadat Farboud, Iman Karimzadeh, Mohammad Taghi Beigmohammadi. 1. Faculty of Pharmacy, Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran; Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran.
Abstract
STUDY OBJECTIVE: To evaluate the effects of topical atorvastatin on the healing process of pressure ulcers in critically ill patients. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING:Medical-surgical intensive care unit of a university-affiliated teaching hospital in Tehran, Iran. PATIENTS: One hundred four patients with stage I or II pressure ulcers, graded according to the 2-digit Stirling Pressure Sore Severity Scale. INTERVENTION: Patients were randomized to receive topical atorvastatin 1% ointment (51 patients [atorvastatin group]) or placebo ointment (53 patients [control group]) applied once/day to pressure ulcers for 14 days in addition to standard care for pressure ulcers. MEASUREMENTS AND MAIN RESULTS: The efficacy of each treatment was assessed on days 7 and 14. Efficacy was determined based on the degree of healing of the existing pressure ulcer by using the 2-digit Stirling scale. The baseline stage of the pressure ulcers did not differ significantly between the control and atorvastatin groups. However, the mean ± SD stage of pressure ulcers significantly decreased in the atorvastatin group compared with the control group on day 7 (0.97 ± 0.76 vs 1.74 ± 0.75, p<0.01) and day 14 (0.42 ± 0.67 vs 1.71 ± 0.78, p<0.01) of treatment. In addition, the mean ± SD surface areas of ulcers in the atorvastatin group were significantly declined compared with the control group after 7 days (5.55 ± 4.55 vs 9.41 ± 5.03 cm², p<0.01) and 14 days (3.72 ± 4.45 vs 10.41 ± 6.41 cm², p<0.01) of treatment. CONCLUSION: Topical application of atorvastatin ointment 1% for 14 days in addition to standard care significantly accelerated the healing of stage I or II pressure ulcers in critically ill patients.
RCT Entities:
STUDY OBJECTIVE: To evaluate the effects of topical atorvastatin on the healing process of pressure ulcers in critically ill patients. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Medical-surgical intensive care unit of a university-affiliated teaching hospital in Tehran, Iran. PATIENTS: One hundred four patients with stage I or II pressure ulcers, graded according to the 2-digit Stirling Pressure Sore Severity Scale. INTERVENTION: Patients were randomized to receive topical atorvastatin 1% ointment (51 patients [atorvastatin group]) or placebo ointment (53 patients [control group]) applied once/day to pressure ulcers for 14 days in addition to standard care for pressure ulcers. MEASUREMENTS AND MAIN RESULTS: The efficacy of each treatment was assessed on days 7 and 14. Efficacy was determined based on the degree of healing of the existing pressure ulcer by using the 2-digit Stirling scale. The baseline stage of the pressure ulcers did not differ significantly between the control and atorvastatin groups. However, the mean ± SD stage of pressure ulcers significantly decreased in the atorvastatin group compared with the control group on day 7 (0.97 ± 0.76 vs 1.74 ± 0.75, p<0.01) and day 14 (0.42 ± 0.67 vs 1.71 ± 0.78, p<0.01) of treatment. In addition, the mean ± SD surface areas of ulcers in the atorvastatin group were significantly declined compared with the control group after 7 days (5.55 ± 4.55 vs 9.41 ± 5.03 cm², p<0.01) and 14 days (3.72 ± 4.45 vs 10.41 ± 6.41 cm², p<0.01) of treatment. CONCLUSION: Topical application of atorvastatin ointment 1% for 14 days in addition to standard care significantly accelerated the healing of stage I or II pressure ulcers in critically ill patients.
Authors: Anna Niezgoda; Andrzej Winnicki; Tomasz Kosmalski; Bogna Kowaliszyn; Jerzy Krysiński; Rafał Czajkowski Journal: Trials Date: 2019-01-25 Impact factor: 2.279