Evaluation of the effect of topical formulation of whey protein on the prevention of pressure ulcer in patients admitted to the intensive care unit

Evaluation of the effect of topical formulation of whey protein on the prevention of pressure ulcer in patients admitted to the intensive care unit

Randomized, double blinded, controlled, clinical trial with a parallel group was designed among 80 patients (40 patients in each group) . Card shuffling was used for randomization.

This randomized, clinical trial was designed to evaluate the effect of topical formulation of whey protein on prevention of pressure ulcer. For this evaluation, topical cream of whey protein 10% with eucerin as the base, was applied in the sacrum area of critically ill patients admitted to ICU, twice daily for 7 days, and compared its effect with eucerin cream as a placebo. Patients were followed daily for pressure ulcer based on PUSH criteria. This is a double blinded study, that means participants, and the assessors of the outcomes are unaware of the study group, and moreover seemingly identical topical formulations were used in intervention and control groups.

Inclusion criteria: 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 Exclusion criteria: 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

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.

Pressure ulcer PUSH score

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.

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.