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:
- Mouth rinses with chlorhexidine-based solution at a concentration of 0.12%, using as a vehicle to 7% ethyl alcohol.
- 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:
- The rate of the oral colonization by gram-negative bacteria initiation of chemotherapy.
- The rate of oral colonization by gram-negative bacteria after 10 days of initiation of chemotherapy.
- 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