NCT02414581

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Hospital Regional de Alta Especialidad del Bajio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neutropenia

Interventions

Type	Name	Description
DRUG	chlorhexidine 0.12%/Ethyl alcohol 7%	Mouth rinses with chlorhexidine 0.12%-based solution
DRUG	Ethyl Alcohol 7%	Mouth rinses with Ethyl Alcohol 7%-based solution
DRUG	Chlorhexidine 2%/Ethyl alcohol 7%	Mouth rinses with chlorhexidine 2%-based solution

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2015-04-10
• Last updated: 2018-05-25

Locations

1 site across 1 country: Mexico