NCT02753387

Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Surgical site infections are an important health indicator for hospitals and a significant medico-economic issue. The aim of the study is to assess the impact of chlorhexidine mouthwash performed before surgery on the bacterial colonization of the pharyngeal mucosa.

Detailed description

The main objective is to reduce the number of patients with significant pathogenic bacterial colonization for pharyngeal mucosa at the end of the surgery. Oral flora is the same as the pharyngeal flora, so this suggests that the action of the oral mouthwash may also act in pharyngeal mucosa by buccopharyngeal communication. Patients will be randomized into two groups : * preoperative oral preparation with sodium chloride (NaCl) 0.9% (control group) * preoperative oral preparation with chlorhexidine (experimental group) A quantitative and qualitative analysis will be performed from samples collected during the surgery : before mouthwash (T0), after mouthwash (T1), before intubation in the operating room (T2), after intubation (T3), before incision (T4) and just before the end of the intervention on the mucosal scar (T5)

Conditions

• Bacterial Infection

Interventions

Type	Name	Description
DRUG	Chlorhexidine	4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio
DEVICE	NaCl 0.9 %	4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %

Timeline

• Start date: 2016-05-23
• Primary completion: 2018-09-05
• Completion: 2018-09-05
• First posted: 2016-04-27
• Last updated: 2018-12-20

Locations

1 site across 1 country: France