Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02414581
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
Universidad de Guanajuato
Information provided by (Responsible Party):
Lauro Fabian Amador Medina, 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

Condition or disease Intervention/treatment Phase
Neutropenia Drug: chlorhexidine 0.12%/Ethyl alcohol 7% Drug: Ethyl Alcohol 7% Drug: Chlorhexidine 2%/Ethyl alcohol 7% Phase 3

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: Chlorhexidine 0.12% & Ethyl Alcohol 7%
Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days.
Drug: chlorhexidine 0.12%/Ethyl alcohol 7%
Mouth rinses with chlorhexidine 0.12%-based solution

Active Comparator: Ethyl Alcohol 7%
Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days.
Drug: Ethyl Alcohol 7%
Mouth rinses with Ethyl Alcohol 7%-based solution

Experimental: Chlorhexidine 2% & Ethyl Alcohol 7%
Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days.
Drug: Chlorhexidine 2%/Ethyl alcohol 7%
Mouth rinses with chlorhexidine 2%-based solution




Primary Outcome Measures :
  1. Rate of oral colonization by gram-negative bacteria [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Rate of oral colonization by gram-negative bacteria at the start of chemotherapy in each study arm. [ Time Frame: Baseline ]
  2. Identify microbiologically gram-negative bacteria that colonize the oral cavity in each study arm [ Time Frame: 10 days ]
  3. Number of participants with presence of severe neutropenia and fever in each study group. [ Time Frame: 10 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414581


Locations
Layout table for location information
Mexico
Hospital Regional Alta Especialidad Bajio
Leon, Guanajuato, Mexico, 37660
Sponsors and Collaborators
Hospital Regional de Alta Especialidad del Bajio
Universidad de Guanajuato
Investigators
Layout table for investigator information
Principal Investigator: Lauro F Amador, Researcher Hospital Regional Alta Especialidad Bajio

Publications of Results:
Layout table for additonal information
Responsible Party: Lauro Fabian Amador Medina, Researcher, Hospital Regional de Alta Especialidad del Bajio
ClinicalTrials.gov Identifier: NCT02414581     History of Changes
Other Study ID Numbers: Ci-HRAEB-2015-004
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: September 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents