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Prevention of Sacral Pressure Ulcers With Preventive Dressings (SACRESS)

Primary Purpose

Grade I to Grade IV Pressure Ulcers in Higher Risk Patients

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mepilex® Border Sacrum dressings
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Grade I to Grade IV Pressure Ulcers in Higher Risk Patients focused on measuring pressure ulcer, dressing, prevention, higher risk patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Hospital of Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mepilex® Border Sacrum dressings

Standard Care

Arm Description

Mepilex® Border Sacrum dressings

Standard Care

Outcomes

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).
till hospital release, max 8 weeks

Secondary Outcome Measures

Full Information

First Posted
July 11, 2012
Last Updated
July 20, 2015
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01640418
Brief Title
Prevention of Sacral Pressure Ulcers With Preventive Dressings
Acronym
SACRESS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grade I to Grade IV Pressure Ulcers in Higher Risk Patients
Keywords
pressure ulcer, dressing, prevention, higher risk patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mepilex® Border Sacrum dressings
Arm Type
Experimental
Arm Description
Mepilex® Border Sacrum dressings
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard Care
Intervention Type
Device
Intervention Name(s)
Mepilex® Border Sacrum dressings
Intervention Description
Mepilex® Border Sacrum dressings
Primary Outcome Measure Information:
Title
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).
Description
till hospital release, max 8 weeks
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Bouvy
Organizational Affiliation
Academic Hospital of Maastricht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Hospital of Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

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Prevention of Sacral Pressure Ulcers With Preventive Dressings

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