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

Not Applicable

Withdrawn

• Conditions: Healing Ulcer
• Interventions: Device: SacralSaver; Other: Standard Care of Treatment

• Registration Number: NCT03211910
• Lead Sponsor: Richmond University Medical Center

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-29
• Study Start: 2023-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

• There are no age, gender or co-morbidity exclusions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SacralSaver	SacralSaver	SacralSaver
Standard Care of Treatment	Standard Care of Treatment	Participants will be treated with standard of care treatment.

Primary Outcome Measures

Name	Time	Method
Bubble wrap mattress for Pressure Ulcer prevention, measured by a ruler (cm)	6 weeks	This pilot study of 30 participants (15 control, 15 experimental) will test the safety and efficacy of using a bubble wrap mattress for pressure ulcer. Participants in one group would receive standard of care treatment and the other group would receive the intervention of the bubble wrap mattress. Participants would be followed for 6 weeks to assess wound healing and tolerance of the treatment. of ulcers. The outcome measure will measure 30 participants, 15 treated with the SacralSavers device and 15 participants with standard of care treatment up to the resolution of the participant's ulcer.

Trial Locations

Locations (1)

Richmond University Medical Center; 🇺🇸 Staten Island, New York, United States