Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Bubble wrap mattress for Pressure Ulcer prevention, measured by a ruler (cm)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Bubble wrap mattress for Pressure Ulcer prevention, measured by a ruler (cm)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported