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Pilot Study on Transient Bacteremia and Blood Stream Infections After Invasive Dental Procedures in Cancer Patients With Central Venous Catheters


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Pilot Study on Transient Bacteremia and Blood Stream Infections After Invasive Dental Procedures in Cancer Patients With Central Venous Catheters

Inclusion Criteria


Inclusion criteria

- Patients willing and able to provide written informed consent for the study.

- Patients diagnosed with cancer and being treated at the University of Connecticut
Health Center.

- Patients scheduled to receive or who have received a central venous catheter

- Patients who have at least one tooth.

Exclusion criteria

- Patients under the age of 18

- Patients who have received any antibacterial in the time period starting 48 hours
before the dental cleaning. This includes systemic antibacterials and topical
antibacterials in the oral cavity or at/through the CVC site. (Topical antibacterials
at other sites are allowed; antifungal and antiviral agents in any form are allowed).

- Patients who plan to use antibacterials within the 24 hours after the procedure
(until the final blood sample is obtained).

- Patients with a documented blood stream infection within 1 month prior to proposed
dental cleaning.

- Patients with a clinically significant coagulation disorder or patients on warfarin.

- Patients who require antibiotic prophylaxis as per ACC/AHA 2007 guidelines, namely;

- patients who have had a cardiac transplantation,

- incomplete cardiac valve repair,

- complete cardiac valve repair in last 6 months,

- prior history of infective endocarditis ,

- patients with a prosthetic cardiac valve.

- Patients with any other condition which might preclude participation in the opinion
of the patient's physician(s) or the study PI's.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To determine the incidence of transient bacteremia and established blood-stream infections (BSIs) by oral microorganisms in cancer patients with CVCs after an invasive dental procedure

Outcome Description:

Blood cultures drawn before dental cleaning, 20 minutes after starting procedure, 30 minutes after finishing the procedure and at 24 hours after starting the procedure. Records reviewed at one month and six months post procedure for bloodstream or central venous catheter infection.

Outcome Time Frame:

Two days, 1 month, 6 months

Safety Issue:

Yes

Principal Investigator

Rajesh V Lalla, DDS, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Connecticut Health Center

Authority:

United States: Institutional Review Board

Study ID:

09-059-2

NCT ID:

NCT00798330

Start Date:

September 2012

Completion Date:

December 2012

Related Keywords:

  • Cancer
  • Cancer
  • Blood stream infections
  • Bacteremia
  • Dental procedure
  • Central venous catheters
  • Mediport
  • PICC line

Name

Location

University of Connecticut Health Center Farmington, Connecticut  06360-7106