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Efficacy of Topical Atorvastatin for the Treatment of Pressure Ulcers: A Randomized Clinical Trial

Authors

  • Shadi Farsaei,

    1. Faculty of Pharmacy, Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran
    2. Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran
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  • Hossein Khalili,

    Corresponding author
    1. Faculty of Pharmacy, Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran
    • Address for correspondence: Hossein Khalili, Department of Clinical Pharmacy, Faculty of pharmacy, Tehran University of Medical Sciences, P.O. Box 14155/6451, Tehran 1417614411, Iran; e-mail: khalilih@tums.ac.ir.

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  • Effat Sadat Farboud,

    1. Faculty of Pharmacy, Department of Pharmaceutics, Tehran University of Medical Sciences, Tehran, Iran
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  • Iman Karimzadeh,

    1. Faculty of Pharmacy, Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran
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  • Mohammad Taghi Beigmohammadi

    1. Department of Anesthesiology and Critical Care Medicine, Imam Khomeini Hospital, Tehran University of Medical Sciences, Tehran, Iran
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  • This study was supported by a grant from the Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Iranian Registry of Clinical Trials identifier: IRCT201102273449N4

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.

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