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

Study Overview
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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.

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.

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

Conditions
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Healing Ulcer

Intervention / Treatment
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* Device: SacralSaver
* Other: Standard Care of Treatment


Participation Criteria
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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. Exclusion Criteria: There are no age, gender or co-morbidity exclusions

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Care of Treatment<br>Participants will be treated with standard of care treatment. | Other: Standard Care of Treatment<br>* Standard Care of Treatment<br>|
| Active Comparator: SacralSaver<br>SacralSaver | Device: SacralSaver<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bubble wrap mattress for Pressure Ulcer prevention, measured by a ruler (cm) | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacral and trochenteric pressure ulcers