Dental Study in Cancer Patients With Central Venous Catheters

NCT00798330 | Completed DMC

• 2 other identifiers: 09-059-2786-001
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Two days, 1 month, 6 months

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rajesh Lalla: lead

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (1)

• Usmani S, Choquette L, Bona R, Feinn R, Shahid Z, Lalla RV. Transient bacteremia induced by dental cleaning is not associated with infection of central venous catheters in patients with cancer. Oral Surg Oral Med Oral Pathol Oral Radiol. 2018 Apr;125(4):286-294. doi: 10.1016/j.oooo.2017.12.022. Epub 2018 Jan 11.

  PMID: 29428697 RESULT

Related Links

• Publication describing results of this study

MeSH Terms

Conditions

Neoplasms; Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rajesh V Lalla, DDS, Ph.D

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, School of Dental Medicine

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

US (1)