NCT03211910

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Richmond University Medical Center · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healing Ulcer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-31
• Completion: 2025-12-30
• First posted: 2017-07-07
• Last updated: 2021-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study