Healing UlcerNCT03211910
Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers
A study testing SacralSaver in people with Healing Ulcer, run by Richmond University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healing Ulcer
- What is being tested?
- SacralSaver
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There are no age, gender or co-morbidity exclusions
Trial locations and contacts
1 site in 1 country.
United States1 site
Richmond University Medical Center
Staten Island, New York, 10310
About this study
The purpose of the study is to investigate the ability of the product "Sacral Saver," to prevent and /or help healing bed sores.
Read the 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.
- Conditions
- Healing Ulcer
- Being tested
- SacralSaver, Standard Care of Treatment
- Keywords
- Sacral and trochenteric pressure ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SacralSaverDevice
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.
Standard Care of TreatmentOther
Standard Care of Treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard Care of Treatment | Placebo comparator | Participants will be treated with standard of care treatment. Receives: Other: Standard Care of Treatment |
| SacralSaver | Active comparator | SacralSaver Receives: Device: SacralSaver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Why it stopped: Funding issue of the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healing UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richmond University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis A Bloomfield, MD, Principal investigator, Richmond University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211910
- Sponsor's protocol ID
- 2017-04-11
- Status last verified
- Sep 2021
- First submitted
- 1 Jun 2017
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bluestein D, Javaheri A. Pressure ulcers: prevention, evaluation, and management. Am Fam Physician. 2008 Nov 15;78(10):1186-94.
PubMed 19035067Macon L, Sloan M, What you should know about decubitus ulcers. November 2015
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.
PubMed 16926357Medical 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.
PubMed 23074533Kirman CN.Pressure ulcer and wound care.Medscape.June 2016
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers
- ClinicalTrials.gov ID
- NCT03211910
- Acronym / sponsor ID
- 2017-04-11
- Conditions
- Healing Ulcer
- Keywords
- Sacral and trochenteric pressure ulcers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issue of the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Richmond University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care of Treatment | Placebo comparator | Other: Standard Care of TreatmentParticipants will be treated with standard of care treatment. |
| SacralSaver | Active comparator | Device: SacralSaverSacralSaver |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no age, gender or co-morbidity exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SacralSaverSacral 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. | Device | SacralSaver |
| Standard Care of TreatmentStandard Care of Treatment | Other | Standard Care of Treatment |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 19035067Bluestein D, Javaheri A. Pressure ulcers: prevention, evaluation, and management. Am Fam Physician. 2008 Nov 15;78(10):1186-94.
- BackgroundMacon L, Sloan M, What you should know about decubitus ulcers. November 2015
- Background: PubMed 16926357Reddy 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.
- Background: PubMed 23074533Medical 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.
- BackgroundKirman CN.Pressure ulcer and wound care.Medscape.June 2016
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis A Bloomfield, MD principal investigator
Richmond University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SacralSaver in people with Healing Ulcer, run by Richmond University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bubble wrap mattress for Pressure Ulcer prevention, measured by a ruler (cm) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03211910, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.