Clinical Trial: Pressure Ulcer Prevention in Intensive Care Unit (ICU)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Randomised Controlled Trial of the Effectiveness of Absorbent Silicone Self Adherent Dressings in the Prevention of Sacral and Heel Pressure Ulcers in Trauma

Brief Summary:

The study is designed as a randomised controlled trial of trauma patients admitted to the Royal Melbourne Hospital (RMH) Emergency Department (ED) and subsequently transferred to the Intensive Care Unit (ICU). Patients meeting the study inclusion criteria will be randomly allocated to either the control group that will receive usual pressure ulcer prevention strategies or the trial group that will receive usual care plus have a Mepilex Border Sacrum dressing applied to their sacrum and Mepilex Boarder Heel dressing applied to each heel in the ED.

Hypothesis:Patients treated with Mepilex Border dressings will have a lower incidence rate of sacral and heel pressure ulcer development than patients receiving standard care.


Detailed Summary:

Aims

To determine the effectiveness of Mepilex Border dressings in preventing sacral and heel pressure ulcer development

To determine the cost effectiveness of Mepilex Border dressings in preventing sacral and heel pressure ulcers.

Primary endpoint

Incidence rates of pressure ulcers in ICU expressed as the total number of pressure ulcers developed per week in both groups

Secondary endpoint

Cost of trial dressings to prevent pressure ulcers Cost of the management of developed pressure ulcers

Hypothesis

Patients treated with Mepilex Border dressings will have a lower incidence rate of sacral and heel pressure ulcer development than patients receiving standard care.

Subjects and Sampling

All trauma and critically ill patients admitted to ED and defined by the ED as being trauma and/or critically ill. These patients will subsequently be transferred to ICU over a six (6) month period commencing January 2010

Sample size

The investigators calculate that to detect a decrease in the ICU pressure ulcer incidence rate of 3.5% (from 4% to 0.5%) in the intervention group with power set at 80% and alpha of 0.05 will require a total of 220 patients per group.

Randomisation

Subjects will be randomised to either the intervention group or to the contro
Sponsor: Melbourne Health

Current Primary Outcome: Pressure ulcer incidence [ Time Frame: Weekly ]

Number of pressure ulcers developed in the ICU per week


Original Primary Outcome: Same as current

Current Secondary Outcome: Cost [ Time Frame: Weekly ]

The cost of treating developed pressure versus the cost of preventing the development of pressure ulcers


Original Secondary Outcome: Same as current

Information By: Melbourne Health

Dates:
Date Received: May 17, 2011
Date Started: June 2011
Date Completion:
Last Updated: May 8, 2015
Last Verified: May 2015