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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01613365
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : August 7, 2015
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

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 or disease Intervention/treatment Phase
Infections and Respiratory Infectious Drug: Chlorhexidine Gluconate Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2012
Primary Completion Date : May 2015
Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: chlorhexidine gluconate Drug: Chlorhexidine Gluconate
Oropharyngeal and nasopharyngeal decontamination with Chlorhexidine Gluconate
Experimental: placebo Drug: Placebo
Oropharyngeal and nasopharyngeal decontamination with placebo

Primary Outcome Measures :
  1. proportion of patients requiring ventilatory support [ Time Frame: 36 MONTHS ]

Secondary Outcome Measures :
  1. occurrence of documented hospital-acquired respiratory infections [ Time Frame: 36 MONTHS ]
  2. occurrence of documented non-respiratory hospital-acquired infections [ Time Frame: 36 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01613365

Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
Principal Investigator: D'JOURNO BENOIT AP HM

Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT01613365     History of Changes
Other Study ID Numbers: 2011-004536-63
2011-24 ( Other Identifier: AP HM )
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents