- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02565797
Comparative Prevention-effectiveness Trial of DabirAIR Overlay System
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and Female subjects
- 18 years of age and older
- Pre-planned neurosurgical procedure lasting more than 2.5 hours
Exclusion Criteria:
- Emergent cases without adequate documentation
- Patients with pre-existing pressure ulcer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 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.
|
Experimental: 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 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.
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Peri-operative (up to 5 days from date of surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events related to use of DabirAIR overlay
Time Frame: Peri-operative (up to 5 days from date of surgery)
|
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.
|
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)
|
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.
|
Peri-operative (up to 5 days from date of surgery)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: aamir siddiqui, md, Henry Ford Health System
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOS-2015-CT01-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pressure Ulcer
-
The Cleveland ClinicRecruitingStage 1 Pressure Ulcer | Stage 2 Pressure UlcerUnited States, Austria
-
University GhentCare of Sweden ABCompletedPressure Ulcer | Pressure Injury | Pressure Ulcer, Buttock | Pressure SoreBelgium
-
Integra LifeSciences CorporationSt Vincent's HospitalCompletedPressure Ulcer | Pressure Ulcers Stage III | Pressure Ulcer, Stage IVUnited States
-
Our Lady of Maryknoll HospitalWong Tai Sin HospitalUnknownPressure Ulcers Stage III | Pressure Ulcer, Stage IVHong Kong
-
ULURU Inc.United States Department of DefenseRecruitingPressure Ulcers Stage II | Pressure Ulcers Stage III | Pressure Ulcer, Stage IVUnited States
-
Bayside HealthCompletedLength of ICU Stay | Pressure Ulcer, Area | Pressure Ulcer, Grade | Albumin Level | Risk ScoreAustralia
-
University of PittsburghUnited States Department of Defense; Georgia Institute of TechnologyCompletedPressure Ulcer | Pressure Injury | Pressure Ulcer, ButtockUnited States
-
Istituto Ortopedico RizzoliCompleted
-
Istanbul Medipol University HospitalCompletedPressure Ulcers Stage III | Pressure Ulcer, Stage IV
-
Charite University, Berlin, GermanyCompletedPressure Ulcer PreventionGermany
Clinical Trials on DabirAIR alternating pressure overlay
-
Wellell FranceClin-ExpertsCompleted
-
Northeast Center for Rehabilitation and Brain InjuryProbed Medical USAUnknown
-
Charite University, Berlin, GermanyCompleted
-
Radboud University Medical CenterCompletedPlasmodium Falciparum MalariaNetherlands
-
Sahlgrenska University Hospital, SwedenCompletedLiver Failure | Acute Kidney InjurySweden