Pressure UlcerNCT02565797
Comparative Prevention-effectiveness Trial of DabirAIR Overlay System
A study testing DabirAIR alternating pressure overlay in people with Pressure Ulcer, run by Dabir Surfaces Inc at 1 site in United States.
Trial summary
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- DabirAIR alternating pressure overlay
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female subjects
- 18 years of age and older
- Pre-planned neurosurgical procedure lasting more than 2.5 hours
Who cannot join
- Emergent cases without adequate documentation
- Patients with pre-existing pressure ulcer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Point-of-care, Pragmatic Comparative Prevention-effectiveness Trial of DabirAIR Alternating Pressure Overlay System to Reduce Hospital-acquired Pressure Ulcers in the Peri-operative Setting.
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting. The primary objective of the study is to compare the prevention-effectiveness (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care pressure-relieving device(s) (control group) peri-operatively to discharge.
Read the detailed description
Pressure ulcers (PUs) are localized skin or underlying tissue injury resulting from pressure or from pressure combined with shear or friction. In the United States, the annual treatment cost of PUs has been estimated at $11 billion and the cost to manage a single-full thickness PU is almost $70,000. According to Beckrich and Aronovitch, in the U.S., almost 25% of the approximately 1.6 million PUs that develop in acute care settings are acquired intra-operatively during surgeries that last more than three hours. The average estimated cost of treatment for the PUs in surgical patients is $750 million - $1.5 billion per year.
Surgical patients are at high risk for developing pressure ulcers due to the presence of many risk factors that are specific to intra-operative environment. Intra-operative factors that contribute to the development of pressure ulcers include patient weight, age, type of surgery, time on operating table longer than 2.5 hrs, anesthetic agents, extra-corporeal circulation, use of heating blanket and presence of vascular diseases.
The DabirAIR overlay system (DOS) is a semi-disposable, multi-patient use, alternating pressure (AP) overlay for surgical and medsurg bed applications. The system was developed as a new and innovative tool for surgeons and perioperative professionals alike to help reduce the risks of deep tissue injury and hospital-acquired pressure ulcers resulting from long surgical procedures in the OR.
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting. The evaluation will be done in patients scheduled for neurosurgical procedures (surgical procedures typically last longer than 3 hours). The primary objective of the study is to compare the prevention-effectiveness (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care pressure-relieving device(s) (control group) peri-operatively to discharge. About 400 patients in the treatment group will have their neurosurgical procedures while lying on the DOS in the operating room. Half of the patients from the treatment group will also be placed on the DOS in the post-op ICUs and recovery units. Retrospective chart reviews will be performed for 400 patients who had neurosurgical procedures while lying on the facility specific standard of care support surfaces in the operating room and post-op ICUs.
It is hypothesized that the treatment group will have lower rate of HAPU compared to the control group due to the pressure relief benefits offered by DOS. Prevention of HAPU will result in improved quality of life and clinical outcomes and cost savings to the healthcare facility.
- Conditions
- Pressure Ulcer
- Being tested
- DabirAIR alternating pressure overlay
- Keywords
- Decubitus Ulcer, Peri-operative, support surface, alternating pressure, neurosurgery
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DabirAIR alternating pressure overlayDevice
DabirAIR alternating pressure overlay is a dynamic support surface that is placed on top a mattress. The DabirAIR overlay provides periodic pressure relief through the alternate inflation and deflation of air cells.
| Study group | Role | What they receive |
|---|---|---|
| DabirAIR overlay-ORICU | Experimental | Patients scheduled for neurosurgical procedures will be placed over DabirAIR alternating pressure overlay (placed on top of standard of care support surface) in the operating room and in the post-op ICU. Receives: Device: DabirAIR alternating pressure overlay |
| DabirAIR overlay-OR | Experimental | Patients scheduled for neurosurgical procedures will be placed over DabirAIR alternating pressure overlay (placed on top of standard of care support surface) in the operating room alone and on standard of care support surface in the post-op ICU. Receives: Device: DabirAIR alternating pressure overlay |
| Control-SOC | No intervention | Patients scheduled for neurosurgical procedures will be placed on standard of care support surface in the operating room and post-op ICU. Data will be abstracted through retrospective chart review. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of peri-operative hospital-acquired pressure ulcers (HAPU)
Investigate the comparative prevention-effectiveness (incidence rate of hospital-acquired pressure ulcers (HAPU)) between DOS (treatment) vs facility specific pressure-relieving device(s) (control) peri-operatively to discharge. The primary outcome of interest in this study is development of a first acquired pressure ulcer in the hospital after surgery to discharge. Pressure ulcers identified within 5 days from date of surgery will be associated with the surgical procedure.
Measured: Peri-operative (up to 5 days from date of surgery)
Secondary outcomes (2)
Adverse events related to use of DabirAIR overlay
Lack of adverse events related to use of DabirAIR overlay (during active use of overlay in OR and ICU/CCU). If any adverse events are reported, the causative factors for the adverse events will be analyzed and the adverse event will be grouped as study-device related or unrelated.
Measured: Peri-operative (up to 5 days from date of surgery)
Cost-benefit of using DabirAIR
Demonstrate the cost-benefit (return-on-investment) of DOS from the perspective of the hospital financial system. The main outcome measure is net financial costs or benefits per patient length of stay (LOS). Direct medical costs attributed to resource utilization, prevention devices and wound care will be estimated during the LOS in the hospital.
Measured: Peri-operative (up to 5 days from date of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pressure 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
- Single group
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dabir Surfaces Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Henry Ford Health System
- Responsible party
- Sponsor
- Investigators
- Aamir Siddiqui, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565797
- Sponsor's protocol ID
- DOS-2015-CT01-1
- Status last verified
- Mar 2021
- First submitted
- 30 Sep 2015
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregate data
Publications
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 16926357Aronovitch SA. Intraoperatively acquired pressure ulcer prevalence: a national study. J Wound Ostomy Continence Nurs. 1999 May;26(3):130-6. doi: 10.1016/s1071-5754(99)90030-x.
PubMed 10711122Feuchtinger J, Halfens RJ, Dassen T. Pressure ulcer risk factors in cardiac surgery: a review of the research literature. Heart Lung. 2005 Nov-Dec;34(6):375-85. doi: 10.1016/j.hrtlng.2005.04.004.
PubMed 16324956Pope R. Pressure sore formation in the operating theatre: 1. Br J Nurs. 1999 Feb 25-Mar 10;8(4):211-4, 216-7. doi: 10.12968/bjon.1999.8.4.6686.
PubMed 10347405Beckrich K, Aronovitch SA. Hospital-acquired pressure ulcers: a comparison of costs in medical vs. surgical patients. Nurs Econ. 1999 Sep-Oct;17(5):263-71. No abstract available.
PubMed 10711175Kemp MG, Keithley JK, Smith DW, Morreale B. Factors that contribute to pressure sores in surgical patients. Res Nurs Health. 1990 Oct;13(5):293-301. doi: 10.1002/nur.4770130505.
PubMed 2236652Hoshowsky VM, Schramm CA. Intraoperative pressure sore prevention: an analysis of bedding materials. Res Nurs Health. 1994 Oct;17(5):333-9. doi: 10.1002/nur.4770170504.
PubMed 8090944Defloor T, De Schuijmer JD. Preventing pressure ulcers: an evaluation of four operating-table mattresses. Appl Nurs Res. 2000 Aug;13(3):134-41. doi: 10.1053/apnr.2000.7653.
PubMed 10960997Tschannen D, Bates O, Talsma A, Guo Y. Patient-specific and surgical characteristics in the development of pressure ulcers. Am J Crit Care. 2012 Mar;21(2):116-25. doi: 10.4037/ajcc2012716.
PubMed 22381988
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Point-of-care, Pragmatic Comparative Prevention-effectiveness Trial of DabirAIR Alternating Pressure Overlay System to Reduce Hospital-acquired Pressure Ulcers in the Peri-operative Setting.
- ClinicalTrials.gov ID
- NCT02565797
- Acronym / sponsor ID
- DOS-2015-CT01-1
- Conditions
- Pressure Ulcer
- Keywords
- Decubitus Ulcer, Peri-operative, support surface, alternating pressure, neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Dabir Surfaces IncIndustry (pharma, biotech, devices)
- Collaborators
- Henry Ford Health System
- Study start
- Nov 2015
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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.
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting. The primary objective of the study is to compare the prevention-effectiveness (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care pressure-relieving device(s) (control group) peri-operatively to discharge.
Detailed description
Pressure ulcers (PUs) are localized skin or underlying tissue injury resulting from pressure or from pressure combined with shear or friction. In the United States, the annual treatment cost of PUs has been estimated at $11 billion and the cost to manage a single-full thickness PU is almost $70,000. According to Beckrich and Aronovitch, in the U.S., almost 25% of the approximately 1.6 million PUs that develop in acute care settings are acquired intra-operatively during surgeries that last more than three hours. The average estimated cost of treatment for the PUs in surgical patients is $750 million - $1.5 billion per year.
Surgical patients are at high risk for developing pressure ulcers due to the presence of many risk factors that are specific to intra-operative environment. Intra-operative factors that contribute to the development of pressure ulcers include patient weight, age, type of surgery, time on operating table longer than 2.5 hrs, anesthetic agents, extra-corporeal circulation, use of heating blanket and presence of vascular diseases.
The DabirAIR overlay system (DOS) is a semi-disposable, multi-patient use, alternating pressure (AP) overlay for surgical and medsurg bed applications. The system was developed as a new and innovative tool for surgeons and perioperative professionals alike to help reduce the risks of deep tissue injury and hospital-acquired pressure ulcers resulting from long surgical procedures in the OR.
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting. The evaluation will be done in patients scheduled for neurosurgical procedures (surgical procedures typically last longer than 3 hours). The primary objective of the study is to compare the prevention-effectiveness (incidence rate of HAPU) between DOS (treatment group) vs facility specific standard of care pressure-relieving device(s) (control group) peri-operatively to discharge. About 400 patients in the treatment group will have their neurosurgical procedures while lying on the DOS in the operating room. Half of the patients from the treatment group will also be placed on the DOS in the post-op ICUs and recovery units. Retrospective chart reviews will be performed for 400 patients who had neurosurgical procedures while lying on the facility specific standard of care support surfaces in the operating room and post-op ICUs.
It is hypothesized that the treatment group will have lower rate of HAPU compared to the control group due to the pressure relief benefits offered by DOS. Prevention of HAPU will result in improved quality of life and clinical outcomes and cost savings to the healthcare facility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DabirAIR overlay-ORICU | Experimental | Device: DabirAIR alternating pressure overlayPatients scheduled for neurosurgical procedures will be placed over DabirAIR alternating pressure overlay (placed on top of standard of care support surface) in the operating room and in the post-op ICU. |
| DabirAIR overlay-OR | Experimental | Device: DabirAIR alternating pressure overlayPatients scheduled for neurosurgical procedures will be placed over DabirAIR alternating pressure overlay (placed on top of standard of care support surface) in the operating room alone and on standard of care support surface in the post-op ICU. |
| Control-SOC | No intervention | –Patients scheduled for neurosurgical procedures will be placed on standard of care support surface in the operating room and post-op ICU. Data will be abstracted through retrospective chart review. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and Female subjects
- 18 years of age and older
- Pre-planned neurosurgical procedure lasting more than 2.5 hours
Key exclusion criteria (2 listed)
- Emergent cases without adequate documentation
- Patients with pre-existing pressure ulcer
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 |
|---|---|---|
| DabirAIR alternating pressure overlayDabirAIR alternating pressure overlay is a dynamic support surface that is placed on top a mattress. The DabirAIR overlay provides periodic pressure relief through the alternate inflation and deflation of air cells. | Device | DabirAIR overlay-OR, DabirAIR overlay-ORICU |
Primary outcome
Incidence rate of peri-operative hospital-acquired pressure ulcers (HAPU)
Time frame: Peri-operative (up to 5 days from date of surgery)
Investigate the comparative prevention-effectiveness (incidence rate of hospital-acquired pressure ulcers (HAPU)) between DOS (treatment) vs facility specific pressure-relieving device(s) (control) peri-operatively to discharge. The primary outcome of interest in this study is development of a first acquired pressure ulcer in the hospital after surgery to discharge. Pressure ulcers identified within 5 days from date of surgery will be associated with the surgical procedure.
2 secondary outcomes
Adverse events related to use of DabirAIR overlay
Time frame: Peri-operative (up to 5 days from date of surgery)
Cost-benefit of using DabirAIR
Time frame: Peri-operative (up to 5 days from date of surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- 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 10711122Aronovitch SA. Intraoperatively acquired pressure ulcer prevalence: a national study. J Wound Ostomy Continence Nurs. 1999 May;26(3):130-6. doi: 10.1016/s1071-5754(99)90030-x.
- Background: PubMed 16324956Feuchtinger J, Halfens RJ, Dassen T. Pressure ulcer risk factors in cardiac surgery: a review of the research literature. Heart Lung. 2005 Nov-Dec;34(6):375-85. doi: 10.1016/j.hrtlng.2005.04.004.
- Background: PubMed 10347405Pope R. Pressure sore formation in the operating theatre: 1. Br J Nurs. 1999 Feb 25-Mar 10;8(4):211-4, 216-7. doi: 10.12968/bjon.1999.8.4.6686.
- Background: PubMed 10711175Beckrich K, Aronovitch SA. Hospital-acquired pressure ulcers: a comparison of costs in medical vs. surgical patients. Nurs Econ. 1999 Sep-Oct;17(5):263-71. No abstract available.
- Background: PubMed 2236652Kemp MG, Keithley JK, Smith DW, Morreale B. Factors that contribute to pressure sores in surgical patients. Res Nurs Health. 1990 Oct;13(5):293-301. doi: 10.1002/nur.4770130505.
- Background: PubMed 8090944Hoshowsky VM, Schramm CA. Intraoperative pressure sore prevention: an analysis of bedding materials. Res Nurs Health. 1994 Oct;17(5):333-9. doi: 10.1002/nur.4770170504.
- Background: PubMed 10960997Defloor T, De Schuijmer JD. Preventing pressure ulcers: an evaluation of four operating-table mattresses. Appl Nurs Res. 2000 Aug;13(3):134-41. doi: 10.1053/apnr.2000.7653.
- Background: PubMed 22381988Tschannen D, Bates O, Talsma A, Guo Y. Patient-specific and surgical characteristics in the development of pressure ulcers. Am J Crit Care. 2012 Mar;21(2):116-25. doi: 10.4037/ajcc2012716.
- Individual participant dataSharing planned: No. Aggregate data
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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.
Aamir Siddiqui, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DabirAIR alternating pressure overlay in people with Pressure Ulcer, run by Dabir Surfaces Inc 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 2 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: finished, as of the sponsor's last update on 29 Mar 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence rate of peri-operative hospital-acquired pressure ulcers (HAPU) (time frame: Peri-operative (up to 5 days from date of surgery)). 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 NCT02565797, which also lists 9 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 Mar 2021.