Comparative Prevention-effectiveness Trial of DabirAIR Overlay System
NCT ID: NCT02565797
Last Updated: 2021-03-29
Study Results
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Basic Information
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COMPLETED
NA
392 participants
INTERVENTIONAL
2015-11-30
2019-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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DabirAIR overlay-ORICU
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.
DabirAIR alternating pressure overlay
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.
DabirAIR overlay-OR
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.
DabirAIR alternating pressure overlay
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.
Control-SOC
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.
No interventions assigned to this group
Interventions
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DabirAIR alternating pressure overlay
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.
Eligibility Criteria
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Inclusion Criteria
* 18 years of age and older
* Pre-planned neurosurgical procedure lasting more than 2.5 hours
Exclusion Criteria
* Patients with pre-existing pressure ulcer
18 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Dabir Surfaces Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Aamir Siddiqui, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Locations
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Henry Ford Health System
Detroit, Michigan, United States
Countries
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References
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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.
Aronovitch 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.
Feuchtinger 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.
Pope 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.
Beckrich 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.
Kemp 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.
Hoshowsky 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.
Defloor 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.
Tschannen 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.
Other Identifiers
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DOS-2015-CT01-1
Identifier Type: -
Identifier Source: org_study_id
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