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

Healing Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03211910
• Other study ID #: 2017-04-11
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2021
• Source: Richmond University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healing Ulcer
• Ulcer

Intervention

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.

Other:
• Standard Care of Treatment
Standard Care of Treatment

Locations

Country	Name	City	State
United States	Richmond University Medical Center	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Richmond University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bluestein D, Javaheri A. Pressure ulcers: prevention, evaluation, and management. Am Fam Physician. 2008 Nov 15;78(10):1186-94. — View Citation

Kirman CN.Pressure ulcer and wound care.Medscape.June 2016

Macon L, Sloan M, What you should know about decubitus ulcers. November 2015

Medical Advisory Secretariat. Management of chronic pressure ulcers: an evidence-based analysis. Ont Health Technol Assess Ser. 2009;9(3):1-203. Epub 2009 Jul 1. — View Citation

Reddy M, Gill SS, Rochon PA. Preventing pressure ulcers: a systematic review. JAMA. 2006 Aug 23;296(8):974-84. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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