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

Richmond University Medical Center

Status: Withdrawn

Conditions: Healing Ulcer

Treatments: Other: Standard Care of Treatment; Device: SacralSaver

Study type: Interventional

Funder types: Other

Identifiers

NCT03211910

2017-04-11

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Standard Care of Treatment

Placebo Comparator group

Description:

Participants will be treated with standard of care treatment.

Treatment:

Other: Standard Care of Treatment

SacralSaver

Active Comparator group

Description:

SacralSaver

Treatment:

Device: SacralSaver