Healing Ulcer
Conditions
Keywords
Sacral and trochenteric pressure ulcers
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.
Interventions
DEVICESacralSaver
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.
OTHERStandard Care of Treatment
Standard Care of Treatment
Sponsors
Richmond University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed