Prevention of Sacral Pressure Ulcers With Preventive Dressings (SACRESS)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014