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

Phase 3

Completed

• Conditions: Neutropenia
• Interventions: Drug: chlorhexidine 0.12%/Ethyl alcohol 7%; Drug: Ethyl Alcohol 7%; Drug: Chlorhexidine 2%/Ethyl alcohol 7%

• Registration Number: NCT02414581
• Lead Sponsor: Hospital Regional de Alta Especialidad del Bajio

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

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-09
• Study First Posted: 2015-04-10
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chlorhexidine 0.12% & Ethyl Alcohol 7%	chlorhexidine 0.12%/Ethyl alcohol 7%	Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days.
Ethyl Alcohol 7%	Ethyl Alcohol 7%	Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days.
Chlorhexidine 2% & Ethyl Alcohol 7%	Chlorhexidine 2%/Ethyl alcohol 7%	Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days.

Primary Outcome Measures

Name	Time	Method
Rate of oral colonization by gram-negative bacteria	10 days

Secondary Outcome Measures

Name	Time	Method
Number of participants with presence of severe neutropenia and fever in each study group.	10 days
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

Trial Locations

Locations (1)

Hospital Regional Alta Especialidad Bajio; 🇲🇽 Leon, Guanajuato, Mexico