Quality Control: A Prospective Analysis of EVD Effectiveness

Catheter Related Infections Clinical Trial

Official title:

Quality Control: A Prospective Analysis of External Ventricular Drain (EVD) Effectiveness

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02484287
• Other study ID #: 4890
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: July 12, 2018

Study information

• Verified date: June 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose and/or hypothesis: To decrease the amount of external ventricular drain (EVD) related catheter infections by comparing the efficacy of Oklahoma University Medicine standard EVD catheters, both impregnated and non-impregnated, in three principle areas: incidence of infection, cost analysis, and average durations of placement, all while maintaining the standards of technique.

Description:

Experimental design: Track external ventricular drain (EVD) associated infections and through quality prospective analysis and compare the usage of standard catheters used by the department here at Oklahoma University, 1) the 35cm Codman Bactiseal rifampin and clindamycin impregnated catheter, 2) the Ventriclear EVD Antibiotic Catheter, and 3) the 36 cm Integra Hermatic large style ventricular catheter, in terms of incidence of infections, cost, duration of placement, and differences in placement technique. Proposed procedure: Monitor for infections associated with and related to EVD placement in patients and assess if infections rates are affected by usage of antibiotic impregnated EVD catheters. Importance of knowledge reasonably expected to result from the research: While use of sterile techniques and periprocedural antibiotics have traditionally been used to combat infection, infection rates remain above goal leading to the question of whether the antibiotic impregnated catheter should be added to the standard of care. With the knowledge gained, the investigators hope to decrease the amount of external ventricular drain related catheter infections and reduce use of prolonged antibiotics.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: July 12, 2018
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who require placement of external ventricular drain.

Exclusion Criteria:

• Prisoners and/or those who may be pregnant.

Related Conditions & MeSH terms

• Catheter Related Infections
• Catheter-Related Infections

Intervention

Device:
• The Integra External Drainage Catheter.
Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
• The Ventriclear EVD Antibiotic Catheter
Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
• The Codman Bactiseal EVD Catheter Set
Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.

Locations

Country	Name	City	State
United States	Oklahoma University Medical Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bohnstedt BN, Nguyen HS, Kulwin CG, Shoja MM, Helbig GM, Leipzig TJ, Payner TD, Cohen-Gadol AA. Outcomes for clip ligation and hematoma evacuation associated with 102 patients with ruptured middle cerebral artery aneurysms. World Neurosurg. 2013 Sep-Oct;80(3-4):335-41. doi: 10.1016/j.wneu.2012.03.008. Epub 2012 Mar 30. — View Citation

Bohnstedt BN, Ziemba-Davis M, Edwards G, Brom J, Payner TD, Leipzig TJ, Scott JA, DeNardo AJ, Palmer E, Cohen-Gadol AA. Treatment and outcomes among 102 posterior inferior cerebellar artery aneurysms: a comparison of endovascular and microsurgical clip ligation. World Neurosurg. 2015 May;83(5):784-93. doi: 10.1016/j.wneu.2014.12.035. Epub 2014 Dec 23. — View Citation

Cohen-Gadol AA, Bohnstedt BN. Recognition and evaluation of nontraumatic subarachnoid hemorrhage and ruptured cerebral aneurysm. Am Fam Physician. 2013 Oct 1;88(7):451-6. — View Citation

Kulwin C, Bohnstedt BN, Payner TD, Leipzig TJ, Scott JA, DeNardo AJ, Cohen-Gadol AA. Aneurysmal acute subdural hemorrhage: prognostic factors associated with treatment. J Clin Neurosci. 2014 Aug;21(8):1333-6. doi: 10.1016/j.jocn.2013.12.010. Epub 2014 Jan 24. — View Citation

Lane B, Bohnstedt BN, Cohen-Gadol AA. A prospective comparative study of microscope-integrated intraoperative fluorescein and indocyanine videoangiography for clip ligation of complex cerebral aneurysms. J Neurosurg. 2015 Mar;122(3):618-26. doi: 10.3171/2014.10.JNS132766. Epub 2014 Dec 19. — View Citation

Ziemba-Davis M, Bohnstedt BN, Payner TD, Leipzig TJ, Palmer E, Cohen-Gadol AA. Incidence, epidemiology, and treatment of aneurysmal subarachnoid hemorrhage in 12 midwest communities. J Stroke Cerebrovasc Dis. 2014 May-Jun;23(5):1073-82. doi: 10.1016/j.jstrokecerebrovasdis.2013.09.010. Epub 2013 Oct 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of EVD Placement	duration of EVD placement in days	24 Months
Other	Cost	Comparable cost of each device	24 months
Primary	Infection Rates of EVD Patients	Infection rates of EVD patients	24 months