Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections (CHLORHEX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01613365
First received: June 5, 2012
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. Vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. These complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. Current management of these complications stands on antibiotics, oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases.

Recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. Previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. These colonizations could act as a major predisposing factor to these postoperative respiratory failures. Because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. This decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. To date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.


Condition Intervention Phase
Infections and Respiratory Infectious
Drug: Chlorhexidine Gluconate
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • proportion of patients requiring ventilatory support [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • occurrence of documented hospital-acquired respiratory infections [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]
  • occurrence of documented non-respiratory hospital-acquired infections [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 470
Study Start Date: May 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chlorhexidine gluconate Drug: Chlorhexidine Gluconate
Oropharyngeal and nasopharyngeal decontamination with Chlorhexidine Gluconate
Experimental: placebo Drug: Placebo
Oropharyngeal and nasopharyngeal decontamination with placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613365

Contacts
Contact: xavier benoit D'journo xavier.djourno@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: xavier benoit D'JOURNO    0491966010    xavier.djourno@ap-hm.fr   
Principal Investigator: xavier benoit D'JOURNO         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
Principal Investigator: D'JOURNO BENOIT AP HM
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01613365     History of Changes
Other Study ID Numbers: 2011-004536-63, 2011-24
Study First Received: June 5, 2012
Last Updated: September 17, 2012
Health Authority: ANSM: Agence nationale de sécurité du Médicament et des produits de sante

Additional relevant MeSH terms:
Communicable Diseases
Infection
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on August 21, 2014