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Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers

NCT03211910 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-09-29

No results posted yet for this study

Summary

The purpose of the study is to investigate the ability of the product "Sacral Saver," to prevent and /or help healing bed sores.

Conditions

  • Healing Ulcer

Interventions

DEVICE

SacralSaver

Sacral Savers is a combination of a strong bubble wrap sheet with a fold at the head end and a nylon sham with a pocket into which the bubble wrap sheet is inserted. This combination is then placed under the fitted sheet on the patient's mid back and the pressure exerted by the lower back of the patient is markedly reduced or nearly eliminated (tested and proven using computer models), thereby preventing the onset of pressure ulcers in the sacro-coccygeal area.

OTHER

Standard Care of Treatment

Standard Care of Treatment

Sponsors & Collaborators

  • Richmond University Medical Center

    lead OTHER

Principal Investigators

  • Dennis A Bloomfield, MD · Richmond University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-12-31
Completion
2025-12-30
FDA Device
Yes

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 NCT03211910 on ClinicalTrials.gov