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

NCT03211910 | Withdrawn FDA Device

• 1 other identifier: 2017-04-11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healing Ulcer

Keywords

Sacral and trochenteric pressure ulcers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard Care of Treatment

PLACEBO COMPARATOR

Participants will be treated with standard of care treatment.

Other: Standard Care of Treatment

SacralSaver

ACTIVE COMPARATOR

SacralSaver

Device: SacralSaver

Interventions

SacralSaver DEVICE

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.

SacralSaver

Standard Care of Treatment OTHER

Standard Care of Treatment

Standard Care of Treatment

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Richmond University Medical Center: lead

Study Sites (1)

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Related Publications (5)

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

  PMID: 19035067 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 16926357 BACKGROUND

• 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.

  PMID: 23074533 BACKGROUND

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

  BACKGROUND

Study Officials

• Dennis A Bloomfield, MD

  Richmond University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: July 7, 2017
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 30, 2025
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)