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| Name | Class |
|---|---|
| Universidad de Guanajuato | OTHER |
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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
Clinical triple-blind randomized controlled trial.
With two arms to the study:
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:
SECONDARY OBJECTIVES
1. The presence of severe neutropenia and fever in each study group during the first 10 days of starting treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorhexidine 0.12% & Ethyl Alcohol 7% | Experimental | Chlorhexidine 0.12% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, twice day for 9 days. |
|
| Ethyl Alcohol 7% | Active Comparator | Ethyl Alcohol 7% without chlorhexidine mouthwashes 15ml by 30 seconds, twice day for 9 days. |
|
| Chlorhexidine 2% & Ethyl Alcohol 7% | Experimental | Chlorhexidine 2% and Ethyl Alcohol 7% mouthwashes 15ml by 30 seconds, once day for 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chlorhexidine 0.12%/Ethyl alcohol 7% | Drug | Mouth rinses with chlorhexidine 0.12%-based solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of oral colonization by gram-negative bacteria | 10 days |
| Measure | Description | 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 |
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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:
Receiving Chemotherapy scheme as a treatment for the underlying disease
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauro F Amador, Researcher | Hospital Regional Alta Especialidad Bajio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Regional Alta Especialidad Bajio | León | Guanajuato | 37660 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12660125 | Result | 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. |
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| ID | Term |
|---|---|
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D000438 |
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| 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 |
|
| Number of participants with presence of severe neutropenia and fever in each study group. | 10 days |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| Alcohols |