Prevention of Sacral Pressure Ulcers With Preventive Dressings

Grade I to Grade IV Pressure Ulcers in Higher Risk Patients Clinical Trial

— SACRESS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640418
• Other study ID #: NL40299.068.12
• Status: Completed
• Phase: N/A
• First received: July 11, 2012
• Last updated: July 20, 2015
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: July 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Grade I to Grade IV Pressure Ulcers in Higher Risk Patients
• Pressure Ulcer

Intervention

Device:
• Mepilex® Border Sacrum dressings
Mepilex® Border Sacrum dressings

Locations

Country	Name	City	State
Netherlands	Academic Hospital of Maastricht	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No