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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.
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 :
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHLORHEXIDINE | Experimental | Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine |
|
| NaCl 0.9 % | Placebo Comparator | Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | Drug | 4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with pharyngeal mucosa colonization (>=10^2 Colony Forming Unit (CFU)/ml of pathogen germs of the oral flora) at the end of the surgery | The percentage of patients with pharyngeal mucosa colonization will be determined from the sample collected on the mucosal scar just before the end of the surgery (T5) | The day of the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with a significant rate of pathogen germs (>=10^2 CFU/ml) at T1 | The number of patients with a significant rate of pathogen germs will be determined from the sample collected after mouthwash (T1) | The day of the surgery |
| Type of oral germs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franck JEGOUX, PH | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Rennes | 35033 | France |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| NaCl 0.9 % | Device | 4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 % |
|
The type of germs will be determined for all the samples collected during the surgery (i.e. 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)) |
| The day of the surgery |
| Number of positive cultures of pathogen germs | The number of positive cultures of pathogen germs will be determined for all the samples collected during the surgery (i.e. 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)) | The day of the surgery |
| Kinetics of the number of CFU/ml | The kinetics of the number of CFU/ml will be determined from all the samples collected during the surgery (i.e. 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)) | The day of the surgery |
| Number of CFU/ml of pathogens germs | The number of CFU/ml of pathogens germs will be determined for all the samples collected during the surgery (i.e. 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)) | The day of the surgery |
| Surgical site infections rate in the postoperative month (standard definition of the Centers for Disease Control and Prevention, Atlanta) | 30 days |
| Number of patients who processed correctly preoperative mouthwash | The day of the surgery |
| Change in the number of CFU/ml of pathogen germs before and after intubation (T2-T3) | The change in the number of CFU/ml of pathogen germs will be assessed using the samples collected before (T2) and after intubation (T3) | The day of the surgery |