NCT01640418

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
253

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

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

July 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

July 11, 2012

Last Update Submit

July 20, 2015

Conditions

Grade I to Grade IV Pressure Ulcers in Higher Risk Patients

Keywords

pressure ulcerdressingpreventionhigher risk patients

Outcome Measures

Primary Outcomes (1)

  • 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

    8 weeks

Study Arms (2)

Mepilex® Border Sacrum dressings

EXPERIMENTAL

Mepilex® Border Sacrum dressings

Device: Mepilex® Border Sacrum dressings

Standard Care

NO INTERVENTION

Standard Care

Interventions

Mepilex® Border Sacrum dressingsDEVICE

Mepilex® Border Sacrum dressings

Mepilex® Border Sacrum dressings

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Hospital of Maastricht

Maastricht, 6229 HX, Netherlands

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nicole Bouvy

    Academic Hospital of Maastricht

    PRINCIPAL INVESTIGATOR

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

July 11, 2012

First Posted

July 13, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

NL(1)