Clinical Trial: Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7% to Reduce the Rate Oral Colonization by Gram-negative Bacteria in Patients With Chemotherapy

Brief Summary: Clinical triple-blind randomized controlled trial to assess the use of two different mouthwashes to reduce the oral colonization by gramnegative bacteria in patients with chemotherapy

Detailed Summary:

Clinical triple-blind randomized controlled trial.

With two arms to the study:

  1. Mouth rinses with chlorhexidine-based solution at a concentration of 0.12%, using as a vehicle to 7% ethyl alcohol.
  2. Mouthwashes with solution based only 7% ethyl alcohol.

GOAL. Assess whether there decrease in the rate of oral colonization by gram-negative bacteria in patients with chemotherapy by using chlorhexidine mouthwash.

SPECIFIC OBJECTIVES:

  1. The rate of the oral colonization by gram-negative bacteria initiation of chemotherapy.
  2. The rate of oral colonization by gram-negative bacteria after 10 days of initiation of chemotherapy.
  3. Identify microbiologically gram-negative bacteria colonizing the oral cavity.

SECONDARY OBJECTIVES

1. The presence of severe neutropenia and fever in each study group during the first 10 days of starting treatment


Sponsor: Hospital Regional de Alta Especialidad del Bajio

Current Primary Outcome: Rate of oral colonization by gram-negative bacteria [ Time Frame: 10 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm. [ Time Frame: Baseline ]
  • Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm [ Time Frame: 10 days ]
  • Number of participants with presence of severe neutropenia and fever in each study group. [ Time Frame: 10 days ]


Original Secondary Outcome: Same as current

Information By: Hospital Regional de Alta Especialidad del Bajio

Dates:
Date Received: April 3, 2015
Date Started: April 2015
Date Completion:
Last Updated: September 27, 2016
Last Verified: September 2016