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IRCT20150221021159N2 IRCT 2020-06-17 Esfahan University of Medical Sciences Evaluation of the effect of topical whey protein on the prevention of pressure ulcer Evaluation of the effect of topical formulation of whey protein on the prevention of pressure ulcer in patients admitted to the intensive care unit 2019-09-25 anticipated 80 Complete https://irct.ir/trial/48784 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Numbers from 1 to 80 were written on the separated cards, and 40 cards were assigned to each group of protein whey and placebo. These cards were placed in the box, and one card was selected randomly from these shuffled cards for each eligible patient, on the study recruitment day. Specific topical cream was applied for each patient based on the number of selected card. It should be mentioned that participants, health care providers, assessor and data collector were not aware of treatment assignment, Blinding description: Seemingly identical topical formulations were used in control and whey protein group. Moreover, participants, health care providers, assessor and data collector unaware of allocated code in each study group. 3 pressure ulcer. Intervention 1: Intervention group: Topical cream of whey protein 10% with eucerin as the base, was made and applied on the sacrum, twice daily, for 7 days. Intervention 2: Control group: Topical placebo cream containing eucerin (without whey protein) was applied on the sacrum, twice daily, for 7 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Shadi Farsaei
Clinical pharmacy and pharmaceutical practices department, Pharmacy faculty, Isfahan university of medical sciences, Hezarjerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7071 Farsaei@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Shadi Farsaei
Clinical pharmacy and pharmaceutical practices department, Pharmacy faculty, Isfahan university of medical sciences, Hezarjerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7071 Farsaei@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Adult patients without pressure ulcer on the intensive care unit (ICU) admission Patients with systolic blood pressure equal or more than 100 millimetre of mercury 18 years no limit Both Patients with prior hospitalization in other wards of the hospital before admission in the ICU Patients with more than 24 hours from ICU admission Patients with diabetes mellitus L89 Pressure ulcer Prevention Prevention Intervention group: Topical cream of whey protein 10% with eucerin as the base, was made and applied on the sacrum, twice daily, for 7 days. Control group: Topical placebo cream containing eucerin (without whey protein) was applied on the sacrum, twice daily, for 7 days. Scale of pressure ulcer using the Pressure Ulcer Scale for Healing (PUSH) tool. Timepoint: From the onset of study, daily, for 7 days. Method of measurement: The Pressure Ulcer Scale for Healing (PUSH) tool. Esfahan University of Medical Sciences Approved 2019-07-09 Ethics committee of Isfahan University of Medical sciences Bldg No. 4, Isfahan University of Medical Sciences and Health Services, Hizar jarib street Isfahan Isfehan Iran (Islamic Republic of)