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Support Surfaces to Prevent Pressure Injuries

NCT02844166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-06-07

No results posted yet for this study

Summary

The presence of pressure injuries has been considered a quality indicator of health care services and efforts has been made to develop guidelines to prevent this issue. Intensive care unit admissions (ICU) are recognized as risk factors to develop pressure injuries due to reduced mobility of critically ill patients and large number of devices and hard technologies that jeopardize preventive measures, such as, decubitus changes. There are not current definitive evidence about the superiority of any support surface to treat or prevent pressure injuries. The objective of the present study is to analyze if the use of viscoelastic support surface in vulnerable critically ill patients decreases the incidence of pressure injury compared with pyramidal foam support surface.

Randomized clinical trial performed in an intensive care unit for adult patients in a philanthropic hospital. Inclusion criteria are patients admitted to ICU with Braden scale ≤ 14. Exclusion criteria are age under 18 years, less than 24 hours of ICU length of stay, contraindication of performing complete institutional preventive measures for support injuries, presence of support injuries at ICU admission or absence of informed consent. Randomization will be made by computerized generated numbers and patients will be allocated in two groups in a ratio of 1:1. All study patients will be cared for according to standard institutional preventive measures. The interventional group will be placed in an ICU bed with viscoelastic support surface and the control group in an ICU bed with pyramidal foam support surface. The main outcome evaluated will be the occurrence of type II pressure injury. Secondary outcomes are the time to the occurrence of pressure injury, length of ICU and hospital stay and 28 days mortality rate. Significance level will be 5%.

Conditions

  • Pressure Ulcer
  • Skin Ulcer

Interventions

OTHER

viscoelastic surface support

Patients will be placed in an ICU bed with viscoelastic surface support

OTHER

pyramidal foam surface support

Patients will be placed in an ICU bed with pyramidal foam surface support

Sponsors & Collaborators

  • Delta Light Ind e Com de Equipamentos Eletrônicos Ltda

    collaborator UNKNOWN

  • Universidade Estadual de Londrina

    lead OTHER

Principal Investigators

  • Cintia MC Grion · UEL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-03-31
Completion
2017-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02844166 on ClinicalTrials.gov