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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-09-30

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

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Detailed Description

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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

Conditions

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Neutropenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Chlorhexidine 0.12% & Ethyl Alcohol 7%

Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days.

Group Type EXPERIMENTAL

chlorhexidine 0.12%/Ethyl alcohol 7%

Intervention Type DRUG

Mouth rinses with chlorhexidine 0.12%-based solution

Ethyl Alcohol 7%

Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days.

Group Type ACTIVE_COMPARATOR

Ethyl Alcohol 7%

Intervention Type DRUG

Mouth rinses with Ethyl Alcohol 7%-based solution

Chlorhexidine 2% & Ethyl Alcohol 7%

Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days.

Group Type EXPERIMENTAL

Chlorhexidine 2%/Ethyl alcohol 7%

Intervention Type DRUG

Mouth rinses with chlorhexidine 2%-based solution

Interventions

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chlorhexidine 0.12%/Ethyl alcohol 7%

Mouth rinses with chlorhexidine 0.12%-based solution

Intervention Type DRUG

Ethyl Alcohol 7%

Mouth rinses with Ethyl Alcohol 7%-based solution

Intervention Type DRUG

Chlorhexidine 2%/Ethyl alcohol 7%

Mouth rinses with chlorhexidine 2%-based solution

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No