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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211910
Recruitment Status : Unknown
Verified July 2017 by Richmond University Medical Center.
Recruitment status was:  Recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Richmond University Medical Center

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.

Condition or disease Intervention/treatment Phase
Healing Ulcer Device: SacralSaver Other: Standard Care of Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Placebo Comparator: Standard Care of Treatment
Participants will be treated with standard of care treatment.
Other: Standard Care of Treatment
Standard Care of Treatment

Active Comparator: SacralSaver
SacralSaver
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211910


Contacts
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Contact: Anita M Trupiano, MS 718-818-2707 atrupiano@rumcsi.org

Locations
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United States, New York
Richmond University Medical Center Recruiting
Staten Island, New York, United States, 10310
Contact: Anita M Trupiano, MS    718-818-2707    atrupiano@rumcsi.org   
Sponsors and Collaborators
Richmond University Medical Center
Investigators
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Principal Investigator: Dennis A Bloomfield, MD Richmond University Medical Center
Publications:
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Responsible Party: Richmond University Medical Center
ClinicalTrials.gov Identifier: NCT03211910    
Other Study ID Numbers: 2017-04-11
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Richmond University Medical Center:
Sacral and trochenteric pressure ulcers
Additional relevant MeSH terms:
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Ulcer
Pathologic Processes