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Completed

NCT Number: NCT02414581

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Regional Alta Especialidad Bajio

León, Guanajuato, 37660, Mexico

About this study

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

  • The presence of severe neutropenia and fever in each study group during the first 10 days of starting treatment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chlorhexidine 0.12%/Ethyl alcohol 7%

Drug

Mouth rinses with chlorhexidine 0.12%-based solution

Ethyl Alcohol 7%

Drug

Mouth rinses with Ethyl Alcohol 7%-based solution

Chlorhexidine 2%/Ethyl alcohol 7%

Drug

Mouth rinses with chlorhexidine 2%-based solution

Primary outcomes

  1. Rate of oral colonization by gram-negative bacteria

    Time frame: 10 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Regional de Alta Especialidad del Bajio

Other

Collaborators

  • Universidad de Guanajuato

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2015
Registry last updated
May 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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