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Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections: a Multicentric, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Infections and Respiratory Infectious

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Trial Information

Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections: a Multicentric, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial


Inclusion Criteria:



- Adult men and women over 18 years

- Submitted to major pulmonary resections for primary lung cancer or pulmonary
metastasis

- Anatomical resections (segmentectomy, lobectomy, pneumonectomy)

- With mediastinal lymph node dissection.

- Patient fit for operation

- After informed consent

Non inclusion criteria:

- Patients < 18 years

- Pulmonary infectious lesions

- Recent respiratory infections

- Tracheostomy

- Swallow difficulties

- Need for non-invasive ventilation before surgery

- Documented sensibility to Chlorhexidine

- Previous ENT cancer

- Previous thoracic surgery

- Patients with an oral assessment score (OAG) >9

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

proportion of patients requiring ventilatory support

Outcome Time Frame:

36 MONTHS

Safety Issue:

No

Principal Investigator

BERNARD BELAIGUES

Investigator Role:

Study Director

Investigator Affiliation:

Assistance Publique hôpitaux de Marseille

Authority:

ANSM: Agence nationale de sécurité du Médicament et des produits de sante

Study ID:

2011-004536-63

NCT ID:

NCT01613365

Start Date:

May 2012

Completion Date:

November 2015

Related Keywords:

  • Infections and Respiratory Infectious
  • Communicable Diseases
  • Infection

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