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

Primary Purpose

Neutropenia

Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
chlorhexidine 0.12%/Ethyl alcohol 7%
Ethyl Alcohol 7%
Chlorhexidine 2%/Ethyl alcohol 7%
Sponsored by
Hospital Regional de Alta Especialidad del Bajio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neutropenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Regional Alta Especialidad Bajio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Chlorhexidine 0.12% & Ethyl Alcohol 7%

Ethyl Alcohol 7%

Chlorhexidine 2% & Ethyl Alcohol 7%

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Rate of oral colonization by gram-negative bacteria

Secondary Outcome Measures

Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm.
Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm
Number of participants with presence of severe neutropenia and fever in each study group.

Full Information

First Posted
April 3, 2015
Last Updated
May 23, 2018
Sponsor
Hospital Regional de Alta Especialidad del Bajio
Collaborators
Universidad de Guanajuato
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1. Study Identification

Unique Protocol Identification Number
NCT02414581
Brief Title
Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Regional de Alta Especialidad del Bajio
Collaborators
Universidad de Guanajuato

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine 0.12% & Ethyl Alcohol 7%
Arm Type
Experimental
Arm Description
Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days.
Arm Title
Ethyl Alcohol 7%
Arm Type
Active Comparator
Arm Description
Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days.
Arm Title
Chlorhexidine 2% & Ethyl Alcohol 7%
Arm Type
Experimental
Arm Description
Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days.
Intervention Type
Drug
Intervention Name(s)
chlorhexidine 0.12%/Ethyl alcohol 7%
Intervention Description
Mouth rinses with chlorhexidine 0.12%-based solution
Intervention Type
Drug
Intervention Name(s)
Ethyl Alcohol 7%
Intervention Description
Mouth rinses with Ethyl Alcohol 7%-based solution
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine 2%/Ethyl alcohol 7%
Intervention Description
Mouth rinses with chlorhexidine 2%-based solution
Primary Outcome Measure Information:
Title
Rate of oral colonization by gram-negative bacteria
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm.
Time Frame
Baseline
Title
Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm
Time Frame
10 days
Title
Number of participants with presence of severe neutropenia and fever in each study group.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauro F Amador, Researcher
Organizational Affiliation
Hospital Regional Alta Especialidad Bajio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional Alta Especialidad Bajio
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37660
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
12660125
Citation
Pitten FA, Kiefer T, Buth C, Doelken G, Kramer A. Do cancer patients with chemotherapy-induced leukopenia benefit from an antiseptic chlorhexidine-based oral rinse? A double-blind, block-randomized, controlled study. J Hosp Infect. 2003 Apr;53(4):283-91. doi: 10.1053/jhin.2002.1391.
Results Reference
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Mouthwash With Chlorhexidine 0.12%/Ethyl Alcohol 7% Compared to Ethyl Alcohol 7%

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