Prophylactic dressing application to reduce pressure ulcer formation in cardiac surgery patients.

PURPOSE: The study was designed to determine if application of a self-adherent silicone border foam dressing would reduce pressure ulcer incidence when compared to standard preventive interventions among patients managed in a cardiac surgery intensive care unit (CSICU). SUBJECTS AND
SETTING: One hundred consecutive patients in the CSICU at Virginia Commonwealth University Medical Center in Richmond participated in the study. Fifteen were subsequently excluded due to incomplete data or failure to remain in the CSICU for at least 48 hours. Of the 100 subjects consecutively enrolled, 56 subjects were assigned to the intervention group with attrition of 6 subjects (6/56), and 39 were assigned to the standard care comparison group with attrition of 4 subjects (4/39). Five study forms were lost and the group assignment of those subjects is unknown.
METHODS: Patients admitted to the CSICU were assigned to either standard treatment or an intervention group consisting of standard preventive care plus application of the silicone border foam dressing. The assignment of subjects to these groups was done in a nonrandom manner, via prestudy room designation (7 intervention rooms/7 standard practice rooms) and room availability on call from the operating room. The charge nurse and bed management staff were unaware of room designation, and staff did not know which group the subjects were assigned to until they admitted the patient and opened the bedside chart that indicated group assignment. Twenty-one covariates were compared between the 2 groups. A Cox proportional hazards model was computed to compare the hazard (risk per unit time) of developing a pressure ulcer between these groups. Propensity score covariate adjustment was performed to adjust for any imbalance between the groups.
RESULTS: Nine pressure ulcers developed during the course of the study. Eight pressure ulcers developed in 4 out of 35 patients who received standard preventive care; 5 were classified as suspected deep tissue injuries and 3 were classified as stage II pressure ulcers. One pressure ulcer developed in 1 out of 50 patients in the intervention group; it was classified as suspected deep tissue injury. No statistically significant difference in any covariate was found between the groups (all P > .058). The group that received standard care had a hazard ratio of 3.6 in relation to the intervention group, but this difference was not statistically significant (P = .3).
CONCLUSION: Pressure ulcer incidence was lower than anticipated over the study period for both groups. No statistically significant difference in pressure ulcer incidence between the intervention and control groups was found. A randomized controlled trial based on a power analysis is needed to more precisely determine the efficacy of a silicone border foam dressing for prevention of pressure ulcers in the intensive care unit.

RCT Entities:   Population Interventions Outcomes