Clinical trial NCT03211910: Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers
Official title: Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healing Ulcer
Keywords: Sacral and trochenteric pressure ulcers
Lead sponsor: Richmond University Medical Center
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Bubble wrap mattress for Pressure Ulcer prevention, measured by a ruler (cm)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
Study officials:
affiliation: Richmond University Medical Center
name: Dennis A Bloomfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bluestein D, Javaheri A. Pressure ulcers: prevention, evaluation, and management. Am Fam Physician. 2008 Nov 15;78(10):1186-94.
citation: Macon L, Sloan M, What you should know about decubitus ulcers. November 2015
citation: Reddy M, Gill SS, Rochon PA. Preventing pressure ulcers: a systematic review. JAMA. 2006 Aug 23;296(8):974-84. doi: 10.1001/jama.296.8.974.
citation: 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.
citation: Kirman CN.Pressure ulcer and wound care.Medscape.June 2016