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Monitoring Physiologic Data in the Development of Pressure Ulcers

NCT02689817 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-11-04

No results posted yet for this study

Summary

Hospital-acquired pressure ulcers (HAPUs) are a well-established serious complication of hospitalization that have serious consequences on patient morbidity and mortality as well as the cost of care. At the core of the problem for patient-centered targeted prevention of HAPUs is the lack of knowledge surrounding the magnitude and duration of pressure necessary to cause pressure ulcers, and the lack of immediate feedback on whether these interventions do anything to substantially offload at risk areas. Previous studies have been inconsistent in their findings of an association between duration of time and HAPU occurrence. While retrospectively this has been investigated, there is currently no substantial prospective, randomized study.

This study seeks to better understand the interface pressures between the patient and his or her support surface and how this relates to the development of pressure ulcers. The effect of patient characteristics and the relationship between total length of time on the operating table and pressure ulcer development will also be assessed.

The findings from this study will significantly add to strengthening the body of evidence regarding pressure ulcer development, specifically the relationship between the magnitude of interface pressure between the patient and the support surface for what duration of time leads to the development of a pressure ulcer. The results will provide critical insight into the physiologic targets healthcare providers should use to develop better pressure ulcer prevention programs, which could ultimately lead to a reduction in the incidence of pressure ulcers.

Conditions

  • Pressure Ulcer
  • Signs and Symptoms

Interventions

DEVICE

Patch

A bandage applied to the sacrum with pressure offloading characteristics and pressure monitoring components in a low-profile housing.

Sponsors & Collaborators

Principal Investigators

  • Justin Sacks, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2019-10-31
Completion
2020-01-31

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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 NCT02689817 on ClinicalTrials.gov