Comparative Prevention-effectiveness Trial of DabirAIR Overlay System

NCT02565797 | Completed

• 1 other identifier: DOS-2015-CT01-1
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Decubitus Ulcer, Peri-operative, support surface, alternating pressure, neurosurgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Peri-operative (up to 5 days from date of surgery)

Secondary Outcomes (2)

• Adverse events related to use of DabirAIR overlay

  Peri-operative (up to 5 days from date of surgery)

• Cost-benefit of using DabirAIR

  Peri-operative (up to 5 days from date of surgery)

Study Arms (3)

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.

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.

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.

Interventions

DabirAIR alternating pressure overlay DEVICE

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; DabirAIR overlay-ORICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female subjects
• years of age and older
• Pre-planned neurosurgical procedure lasting more than 2.5 hours

You may not qualify if:

• Emergent cases without adequate documentation
• Patients with pre-existing pressure ulcer

Sponsors & Collaborators

• Dabir Surfaces Inc: lead
• Henry Ford Health System: collaborator

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (9)

• 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.

  PMID: 16926357 BACKGROUND

• 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.

  PMID: 10711122 BACKGROUND

• 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.

  PMID: 16324956 BACKGROUND

• 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.

  PMID: 10347405 BACKGROUND

• 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.

  PMID: 10711175 BACKGROUND

• 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.

  PMID: 2236652 BACKGROUND

• 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.

  PMID: 8090944 BACKGROUND

• 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.

  PMID: 10960997 BACKGROUND

• 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.

  PMID: 22381988 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aamir Siddiqui, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 1, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)