Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%

Study Overview
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Brief Summary
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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 Description
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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

Official Title
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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

Conditions
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Neutropenia

Intervention / Treatment
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* Drug: chlorhexidine 0.12%/Ethyl alcohol 7%
* Drug: Ethyl Alcohol 7%
* Drug: Chlorhexidine 2%/Ethyl alcohol 7%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18years, no upper age limit. Acceptance of participation in the study. Signature of informed consent. Inpatient and remain hospitalized for at least 10 days. The following haematological diagnosis: acute lymphoblastic leukemia. acute myelogenous leukemia. relapsed non-Hodgkin lymphoma. Receiving Chemotherapy scheme as a treatment for the underlying disease Exclusion Criteria: Patients who choose not to participate in the study. Patients in whom no possible mouthwashes. Patients who willingly choose to withdraw from the study. Patients who develop conditions in which the administration is not possible rinses. Duration of hospital stay less than 10 days, regardless of cause.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine 0.12% & Ethyl Alcohol 7%<br>Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days. | Drug: chlorhexidine 0.12%/Ethyl alcohol 7%<br>* Mouth rinses with chlorhexidine 0.12%-based solution<br>|
| Active Comparator: Ethyl Alcohol 7%<br>Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days. | Drug: Ethyl Alcohol 7%<br>* Mouth rinses with Ethyl Alcohol 7%-based solution<br>|
| Experimental: Chlorhexidine 2% & Ethyl Alcohol 7%<br>Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days. | Drug: Chlorhexidine 2%/Ethyl alcohol 7%<br>* Mouth rinses with chlorhexidine 2%-based solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of oral colonization by gram-negative bacteria |  | 10 days | 

Secondary Outcome Measures

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