NCT01356459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

May 17, 2011

Last Update Submit

May 8, 2015

Conditions

Pressure Ulcers

Keywords

Pressure ulcersICUPrevention

Outcome Measures

Primary Outcomes (1)

  • Pressure ulcer incidence

    Number of pressure ulcers developed in the ICU per week

    Weekly

Secondary Outcomes (1)

  • Cost

    Weekly

Study Arms (2)

Intervention

EXPERIMENTAL

Patients in this arm will have Mepilex dressings applied to their sacrum and heels

Device: Mepilex Border Dressing

Control

NO INTERVENTION

Patients in this arm will have standard care

Interventions

Mepilex Border DressingDEVICE

Soft silicone self adherent dressing

Also known as: Mepilex Border Sacrum, Mepilex Heel
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ED and ICU admission for critical illness and/or major trauma Over 18 years old

You may not qualify if:

  • Less than 18 years old Suspected or actual spinal injury Pre-existing sacral or heel pressure ulcer Trauma to sacral and/or heel area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 19, 2011

Study Start

June 1, 2011

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

AU(1)