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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02414581

Enrollment

Registered

2015-04-10

Start date

2015-04-30

Completion date

2016-09-30

Last updated

2018-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neutropenia

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 description

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

Interventions

DRUGchlorhexidine 0.12%/Ethyl alcohol 7%

Mouth rinses with chlorhexidine 0.12%-based solution

DRUGEthyl Alcohol 7%

Mouth rinses with Ethyl Alcohol 7%-based solution

DRUGChlorhexidine 2%/Ethyl alcohol 7%

Mouth rinses with chlorhexidine 2%-based solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Rate of oral colonization by gram-negative bacteria	10 days

Secondary

Measure	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

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026