Clinical trial · Interventional
Effect of Oral Preparation on Bacterial Colonization of the Pharyngeal Mucosa in Surgery of Head and Neck Cancer
NCT02753387CI-TRIAL-00036228ORAL-ISOcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bacterial Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chlorhexidine | Drug | — | UNRESOLVED |
| NaCl 0.9 % | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CHLORHEXIDINE
- description
- Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of chlorhexidine
- interventionNames
- Drug: Chlorhexidine
- type
- PLACEBO_COMPARATOR
- label
- NaCl 0.9 %
- description
- Patients will receive 1 preoperative oral preparation and 1 peroperative oral preparation of NaCl 0.9%
- interventionNames
- Device: NaCl 0.9 %
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological evidence of cancer regardless of histological type * Surgical treatment requiring mucosal effraction regardless of the surgical approach; * Patient over 18 years old; * Oral cancer, oropharyngeal cancer, hypopharyngeal cancer or laryngeal cancer; * Written and informed patient consent Exclusion Criteria: * Concomitant Vascular Interventions; * Interventional radiology; * Needing of second surgery at a same location during the 30 postoperative days); * Cancer of the paranasal sinus, nasal cavity, skull base, salivary glands, skin, * Neck dissection without mucosal effraction * Thyroid or parathyroid surgery * Size tumor forbidden tumor surgery * Allergy to any tested product; * Concurrent infection the day before or day of surgery * Protected adults (guardianship) and persons deprived of liberty
References
Publications (0)
Data not yet available
No reference posted for this study.