Prevention of Sacral Pressure Ulcers With Preventive Dressings (SACRESS)

This study is currently recruiting participants.
Verified May 2013 by Maastricht University Medical Center
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01640418
First received: July 11, 2012
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk hospitalized patients?


Condition Intervention
Grade I to Grade IV Pressure Ulcers in Higher Risk Patients
Device: Mepilex® Border Sacrum dressings

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    till hospital release, max 8 weeks


Estimated Enrollment: 914
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mepilex® Border Sacrum dressings
Mepilex® Border Sacrum dressings
Device: Mepilex® Border Sacrum dressings
Mepilex® Border Sacrum dressings
No Intervention: Standard Care
Standard Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: ≥18 years
  • Admission in one of the ten high-risk departments of the azM
  • Suspected hospital stay of 5 days or more after admission
  • Braden score 19 or less

Exclusion Criteria:

  • Age: <18 years
  • Pre-existing sacral pressure ulcer
  • Pre-existing trauma to the sacrum
  • Patient is unable to speak Dutch
  • Patients with an inability to give informed consent
  • Patients who are unable to give informed consent within 24h after admission
  • Patients who are unable to give informed consent before surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640418

Contacts
Contact: Ruben Vogels, MD +31433881584 r.vogels@maastrichtuniversity.nl
Contact: Nicole Bouvy +31433875492 n.bouvy@mumc.nl

Locations
Netherlands
Academic Hospital of Maastricht Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Nicole Bouvy    +433875492    n.bouvy@mumc.nl   
Principal Investigator: Nicole Bouvy         
Sub-Investigator: Ruben Vogels         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Nicole Bouvy Academic Hospital of Maastricht
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01640418     History of Changes
Other Study ID Numbers: NL40299.068.12
Study First Received: July 11, 2012
Last Updated: May 1, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
pressure ulcer
dressing
prevention
higher risk patients

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014