Comparative Prevention-effectiveness Trial of DabirAIR Overlay System
NCT02565797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392
Last updated 2021-03-29
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. 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.
Conditions
- Pressure Ulcer
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Henry Ford Health System
collaborator OTHER -
Dabir Surfaces Inc
lead INDUSTRY
Principal Investigators
-
Aamir Siddiqui, MD · Henry Ford Health System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2018-11-30
- Completion
- 2019-12-31
Countries
- United States
Study Locations
More Related Trials
-
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
NCT01011387 ·Status: COMPLETED ·Phase: NA
-
DURAFIBER Ag Post-Market Clinical Follow-Up
NCT03277131 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
NCT00387101 ·Status: TERMINATED ·Phase: PHASE3
-
A Predictive Technology for Prevention of Diabetic Foot Ulcers
NCT04769115 ·Status: COMPLETED ·Phase: NA
-
Evaluating Clinical Acceptance of a NPWT Wound Care System
NCT03670225 ·Status: COMPLETED ·Phase: NA
-
EDX110 Randomized Control Trial for Treatment of DFUs
NCT07209358 ·Status: RECRUITING ·Phase: NA
-
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
NCT05579743 ·Status: RECRUITING ·Phase: NA
-
Comparative Effectiveness of Two Acellular Matrices (Dermacell vs. Integra) for Management of Deep Diabetic Foot Ulcers
NCT03476876 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers
NCT00330265 ·Status: UNKNOWN ·Phase: PHASE2
-
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
NCT02680834 ·Status: TERMINATED ·Phase: NA
-
Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended
NCT02224404 ·Status: COMPLETED ·Phase: NA
-
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Safety, and Performance of ConvaFoam™ Dressings in the Management of Indicated Chronic Wound Types.
NCT05632250 ·Status: COMPLETED ·Phase: NA
-
Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.
NCT02091778 ·Status: COMPLETED ·Phase: NA
-
Negative Pressure Wound Therapy as a Drug Delivery System
NCT02463487 ·Status: COMPLETED ·Phase: NA
-
Comparing the Clinical Outcomes of DermACELL® With Integra® Bilayer Wound Matrix
NCT03285698 ·Status: UNKNOWN ·Phase: NA
-
Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers
NCT00366132 ·Status: UNKNOWN ·Phase: PHASE2
-
Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds
NCT00971048 ·Status: COMPLETED ·Phase: NA
-
The Effect of Shear- Force at the Skin in Patients With Diabetes Mellitus
NCT02348294 ·Status: UNKNOWN ·Phase: NA
-
Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds
NCT01947387 ·Status: COMPLETED
-
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
NCT00847730 ·Status: COMPLETED ·Phase: NA
-
Diabetic Foot Ulcer Prevention System (DFUPS) - Part 2
NCT02579070 ·Status: COMPLETED ·Phase: NA
-
DermaRep™ Device in the Treatment of Venous Leg Ulcers
NCT03699072 ·Status: COMPLETED ·Phase: NA
-
The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs
NCT03640988 ·Status: TERMINATED ·Phase: NA
-
A Safety and Efficacy Study of INTEGRA® Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers
NCT01060670 ·Status: COMPLETED ·Phase: NA
-
NPWTi on Closure of Chronic Pressure Sores
NCT05598398 ·Status: RECRUITING ·Phase: PHASE4