The Topical Formulation of Whey Protein for the Prevention of Pressure Ulcers in Critically Ill Patients: A Novel Intervention in a Randomized-Controlled Clinical Trial

Background: High prevalence of pressure ulcers (PUs) and their complications are important dilemmas in the intensive care unit (ICU). Therefore this study was designed to evaluate the effectiveness of topical whey protein formulation in preventing PUs in patients admitted to the ICU. Materials and Methods: In this randomized placebo-controlled clinical trial under registration number [IRCTdeted for blinded article], 80 eligible ICU patients were randomly allocated to receive topical ointment of whey protein or placebo on the sacrum with a diameter of 15 cm twice daily for seven days, in addition to the routine care. The mean risk score for developing PUs was calculated at baseline using the Braden tool, and the PUSH score was used to assess PUs on days 4, 7, and 14. Patients' related demographic and clinical variables were also collected using a medical record for more evaluation. Results: Our results showed that demographic characteristics and the Braden scores' baseline mean were not significantly different between groups (P > 0.05). The repeated measures ANOVA test revealed that the mean scores of PUs at various times were markedly lower in the whey protein than in the placebo group (P < 0.001). Conclusion: This intervention can be routinely added as effective, safe, inexpensive, and accessible care to reduce the incidence of PUs for patients at risk of developing this injury.