A two-arm cluster randomized control trial to determine the effectiveness of a pressure ulcer prevention bundle for critically ill patients

J Nurs Scholarsh. 2015 May;47(3):237-47. doi: 10.1111/jnu.12136. Epub 2015 Mar 21.


Purpose: This study tested the effectiveness of a pressure ulcer (PU) prevention bundle in reducing the incidence of PUs in critically ill patients in two Saudi intensive care units (ICUs).

Design: A two-arm cluster randomized experimental control trial.

Methods: Participants in the intervention group received the PU prevention bundle, while the control group received standard skin care as per the local ICU policies. Data collected included demographic variables (age, diagnosis, comorbidities, admission trajectory, length of stay) and clinical variables (Braden Scale score, severity of organ function score, mechanical ventilation, PU presence, and staging). All patients were followed every two days from admission through to discharge, death, or up to a maximum of 28 days. Data were analyzed with descriptive correlation statistics, Kaplan-Meier survival analysis, and Poisson regression.

Findings: The total number of participants recruited was 140: 70 control participants (with a total of 728 days of observation) and 70 intervention participants (784 days of observation). PU cumulative incidence was significantly lower in the intervention group (7.14%) compared to the control group (32.86%). Poisson regression revealed the likelihood of PU development was 70% lower in the intervention group. The intervention group had significantly less Stage I (p = .002) and Stage II PU development (p = .026).

Conclusions: Significant improvements were observed in PU-related outcomes with the implementation of the PU prevention bundle in the ICU; PU incidence, severity, and total number of PUs per patient were reduced.

Clinical relevance: Utilizing a bundle approach and standardized nursing language through skin assessment and translation of the knowledge to practice has the potential to impact positively on the quality of care and patient outcome.

Keywords: Bundle care; incidence; intensive care; pressure ulcer.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Cluster Analysis
  • Critical Care Nursing / methods*
  • Critical Illness*
  • Female
  • Humans
  • Incidence
  • Intensive Care Units / statistics & numerical data
  • Kaplan-Meier Estimate
  • Length of Stay / statistics & numerical data
  • Male
  • Middle Aged
  • Pressure Ulcer / epidemiology
  • Pressure Ulcer / etiology
  • Pressure Ulcer / prevention & control*
  • Young Adult