Prevention of Sacral Pressure Ulcers With Preventive Dres... | NCT01640418

Studies
Prevention of Sacral Pressure Ulcers With Preventive Dressings

NCT01640418

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Jul 21, 2015Estimated

Enrollment

253Actual

Phase

Not Applicable

Conditions

Grade I to Grade IV Pressure Ulcers in Higher Risk Patients

Interventions

Mepilex® Border Sacrum dressings

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Jul 11, 2012

First Submission Date that Met QC Criteria

Jul 11, 2012

First Posted Date

Jul 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2015

Last Update Posted Date

Jul 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

253Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mepilex® Border Sacrum dressings	Experimental	Mepilex® Border Sacrum dressings	Device: Mepilex® Border Sacrum dressings
Standard Care	No Intervention	Standard Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mepilex® Border Sacrum dressings	Device	Mepilex® Border Sacrum dressings	Mepilex® Border Sacrum dressings

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicole Bouvy	Academic Hospital of Maastricht	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Hospital of Maastricht		Maastricht		6229 HX	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided