Comparative Prevention-effectiveness Trial of DabirAIR Overlay System

NCT02565797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2021-03-29

No results posted yet for this study

Summary

Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting. The primary objective of the study is to compare the prevention-effectiveness (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care pressure-relieving device(s) (control group) peri-operatively to discharge.

Conditions

  • Pressure Ulcer

Interventions

DEVICE

DabirAIR alternating pressure overlay

DabirAIR alternating pressure overlay is a dynamic support surface that is placed on top a mattress. The DabirAIR overlay provides periodic pressure relief through the alternate inflation and deflation of air cells.

Sponsors & Collaborators

  • Henry Ford Health System

    collaborator OTHER
  • Dabir Surfaces Inc

    lead INDUSTRY

Principal Investigators

  • Aamir Siddiqui, MD · Henry Ford Health System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-11-30
Completion
2019-12-31

Countries

  • United States

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 NCT02565797 on ClinicalTrials.gov