Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections (CHLORHEX)
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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 |
- proportion of patients requiring ventilatory support [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]
- 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 |
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| Contact: xavier benoit D'journo | xavier.djourno@ap-hm.fr |
| 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 | |
| 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 June 18, 2013