Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%
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|ClinicalTrials.gov Identifier: NCT02414581|
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : May 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neutropenia||Drug: chlorhexidine 0.12%/Ethyl alcohol 7% Drug: Ethyl Alcohol 7% Drug: Chlorhexidine 2%/Ethyl alcohol 7%||Phase 3|
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.
- 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.
1. The presence of severe neutropenia and fever in each study group during the first 10 days of starting treatment
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Chlorhexidine 0.12% & Ethyl Alcohol 7%
Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days.
Drug: chlorhexidine 0.12%/Ethyl alcohol 7%
Mouth rinses with chlorhexidine 0.12%-based solution
Active Comparator: Ethyl Alcohol 7%
Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days.
Drug: Ethyl Alcohol 7%
Mouth rinses with Ethyl Alcohol 7%-based solution
Experimental: Chlorhexidine 2% & Ethyl Alcohol 7%
Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days.
Drug: Chlorhexidine 2%/Ethyl alcohol 7%
Mouth rinses with chlorhexidine 2%-based solution
- Rate of oral colonization by gram-negative bacteria [ Time Frame: 10 days ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414581
|Hospital Regional Alta Especialidad Bajio|
|Leon, Guanajuato, Mexico, 37660|
|Principal Investigator:||Lauro F Amador, Researcher||Hospital Regional Alta Especialidad Bajio|