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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-30

Brief Summary

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

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Detailed Description

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The purpose of this research study is to investigate the ability of the product "Sacral Savers." to prevent and/or help healing of bed sores, in patients in health care facilities.

The Sacral saver device consists of a sheet of strong bubble-wrap-like material, folded at one end and covered by a nylon sham with a pocket in which the bubble wrap is placed. The assembled device is placed under the bed sheet in such a way that the small of the back rests on the fold. This will lift the back and reduce the pressure of the buttocks on the bed. When lying on the side, it will reduce the pressure on the hip.

Participants are being asked to participate in this study because you are at risk for, or already have a bedsore on the buttocks or the hip.

Conditions

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Healing Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 • Intervention:: medical device: Bubble wrap mattress has been successful in enhancing wound healing. Wound healing is greater than 20% healing within two weeks documented by measurement of the wound bed or wound healing to less than the dermal layer documented by photography and agreement of healing between research associate and physician . The bubble wrap mattress will be place underneath the participant. Follow-up will occur weekly for 6 weeks.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard Care of Treatment

Participants will be treated with standard of care treatment.

Group Type PLACEBO_COMPARATOR

Standard Care of Treatment

Intervention Type OTHER

Standard Care of Treatment

SacralSaver

Group Type ACTIVE_COMPARATOR

SacralSaver

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Standard Care of Treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Any patient who is immobilized for prolonged periods, either in acute care, or chronic care situations.
* All patients with: paralysis, quadriplegia, paraplegia, trauma patients, requiring prolonged immobilization, patients on ventilators.
* All patients with pre-existing pressure ulcers in the lower back and or hip regions.