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Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation

NCT02526862 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2015-08-18

No results posted yet for this study

Summary

This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM- mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU), compared with other three usual preventive measures which consist in the use of three different medical devices.

Conditions

Interventions

DEVICE

Allevyn Thin®

Protection of the dermis with autoadhesive polyurethane dressing. The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.

DEVICE

Askina Transorbent Border®

Protection of the dermis with semi-permeable hydrogel-foams adhesive dressing. The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.

DEVICE

Linovera®

Protection of the dermis with hyper hydrogenated fatty acids. It will be applied with its doser and gently massaged in chin, cheekbones, nasal and frontal bridge as indicated in the product. It will be checked every six hours for proper hydration and if needed it will be applied again in the same way.

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria Gregorio Marañón

    collaborator OTHER

  • Universidad Rey Juan Carlos

    collaborator OTHER

  • B. Braun Medical SA

    lead INDUSTRY

Principal Investigators

  • David Peña-Otero, M.Sc. · Nurse. Emergency and Critical Care. Hospital General Universitario Gregorio Marañón. Nursing Faculty. Universidad Rey Juan Carlos. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT02526862 on ClinicalTrials.gov