Methods: Experimental two-group design was used to enroll 367 subjects, with Braden5 Score ≤13; intact skin. N=184 randomized to intervention group (IG) receiving the SKIN4 Bundle and Silicone Border Sacrum Dressing and N=183 to Control Group (CG) receiving SKIN4Bundle (usual care). Team did daily skin assessments on all subjects; changed dressing every 3-days. No statistically significant difference in covariate was found in the groups (P= .058). Cox hazard ratio was 3.6 in relation to IG, although it was not statistically significant (P=.3).
Descriptive statistics was used to analyze the study characteristics, and incidence of PUs. Survival analysis was used to determine difference in PU incidence rates per group; logistic regression was used to evaluate potential interactions between demographic and physiological variables between groups and incidence rates.
Results: Sample mean age ±67.5 yrs, Braden5 Score of ±11.2. ICU LOS 6.82 days. Eight PUs developed „Ÿ7 in the CG; and 1 PU in the IG. High-severity of illness was noted in most subjects, (APACHE IV4Mortality Risk .60-.90%). Results show the Border Sacrum Dressing was effective in preventing PUs in 98% of IG (significant at P=.001). Risk factors found to be strong correlates (r=.72) among patients with PUs were „Ÿaltered LOC, vasopressors, increased LOS, mechanical ventilation; >4 comorbidities.
Conclusions: This RCT validates recent studies 1,2, 3 thus, adding more science to guide clinicians to become early adopters of this new wound technology. Border Sacrum Dressing provided superb absorption, and appears to reduce friction, shear, moisture, by providing a barrier between the bed surface/skin. Identifying unique risk factors related to development of PUs should prompt nurses to deploy aggressive preventive measures.