Dental Study in Cancer Patients With Central Venous Catheters

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rajesh Lalla, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00798330
First received: November 25, 2008
Last updated: March 21, 2013
Last verified: March 2013

November 25, 2008
March 21, 2013
September 2012
December 2012   (final data collection date for primary 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 [ Time Frame: Two days, 1 month, 6 months ] [ Designated as safety issue: Yes ]
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.
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 [ Time Frame: Blood cultures drawn before dental cleaning, 20 minutes after starting procedure, 30 minutes after finishing the procedure and at 24 hours after the procedure. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00798330 on ClinicalTrials.gov Archive Site
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Dental Study in Cancer Patients With Central Venous Catheters
Pilot Study on Transient Bacteremia and Blood Stream Infections After Invasive Dental Procedures in Cancer Patients With Central Venous Catheters

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 (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 port or PICC before, 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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Cancer outpatients with central venous catheters (Medport or PICC lines)

Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00798330
09-059-2, 786-001
Yes
Rajesh Lalla, University of Connecticut Health Center
Rajesh Lalla
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Principal Investigator: Rajesh V Lalla, DDS, Ph.D University of Connecticut Health Center
University of Connecticut Health Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP