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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01613365
Acronym
CHLORHEX
Enrollment
474
Registered
2012-06-07
Start date
2012-05-31
Completion date
2015-05-31
Last updated
2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections and Respiratory Infectious

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.

Interventions

DRUGChlorhexidine Gluconate

Oropharyngeal and nasopharyngeal decontamination with Chlorhexidine Gluconate

DRUGPlacebo

Oropharyngeal and nasopharyngeal decontamination with placebo

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
proportion of patients requiring ventilatory support36 MONTHS

Secondary

MeasureTime frame
occurrence of documented hospital-acquired respiratory infections36 MONTHS
occurrence of documented non-respiratory hospital-acquired infections36 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026