Dental Study in Cancer Patients With Central Venous Catheters

Sponsor

Rajesh Lalla (Other)

Overall Status

Completed

CT.gov ID

NCT00798330

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients who are preparing to receive chemotherapy are asked to have their teeth cleaned before starting treatment as standard of care. This research study is being done to see if having dental cleaning increases the chances of bacteria from the mouth getting into the blood stream. It is also being done to see if these bacteria can cause blood stream infections in people who have a Central Venous Catheter (CVC),often called a "port" or a "PICC", placed for giving chemotherapy. It is a well-established fact that we introduce bacteria from the mouth into the bloodstream with activities of daily life including chewing, flossing and brushing teeth. This introduction of bacteria into the blood stream may cause bacteria to stick to the central venous catheter and serve as a source of infection when the immune system is weakened by cancer. The purpose of this research study is to see if we can find bacteria from mouth in blood that is drawn through the CVC, during, and after a dental cleaning procedure. This way, we will be able to assess whether or not this is a potential health risk to cancer patients.

Condition or Disease	Intervention/Treatment	Phase
Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

27 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Outcome Measures

Primary Outcome Measures

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 [Two days, 1 month, 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 American College of Cardiology/American Heart Association (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.