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

Hospital Regional de Alta Especialidad del Bajio60 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Neutropenia

Interventions

chlorhexidine 0.12%/Ethyl alcohol 7%DRUG

Mouth rinses with chlorhexidine 0.12%-based solution

Ethyl Alcohol 7%DRUG

Mouth rinses with Ethyl Alcohol 7%-based solution

Chlorhexidine 2%/Ethyl alcohol 7%DRUG

Mouth rinses with chlorhexidine 2%-based solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients over 18years, no upper age limit. 2. Acceptance of participation in the study. 3. Signature of informed consent. 4. Inpatient and remain hospitalized for at least 10 days. 5. The following haematological diagnosis: 1. acute lymphoblastic leukemia. 2. acute myelogenous leukemia. 3. relapsed non-Hodgkin lymphoma. 6. Receiving Chemotherapy scheme as a treatment for the underlying disease Exclusion Criteria: 1. Patients who choose not to participate in the study. 2. Patients in whom no possible mouthwashes. 3. Patients who willingly choose to withdraw from the study. 4. Patients who develop conditions in which the administration is not possible rinses. 5. Duration of hospital stay less than 10 days, regardless of cause.

Locations (1)

Hospital Regional Alta Especialidad Bajio

León, Guanajuato, Mexico

Outcomes

Primary Outcomes

Rate of oral colonization by gram-negative bacteria

Time frame: 10 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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