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Prevention of Post-operative Pneumonia (POPP)

Phase 2
Terminated
Conditions
Esophageal Cancer
Post-operative Pneumonia
Lung Cancer
Interventions
Registration Number
NCT01446874
Lead Sponsor
Washington University School of Medicine
Brief Summary

Postoperative pneumonia is a major complication in patients undergoing thoracic surgery. It leads to considerable morbidity and contributes to perioperative morbidity. There is evidence in literature that supports the use of strategies for improved oral hygiene and specialized endotracheal tubes in preventing ventilator associated pneumonia (VAP) in mechanically ventilated patients. This study aims at utilizing a combination of these interventions in the perioperative period in patients undergoing planned thoracic surgical procedures.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
150
Inclusion Criteria
  1. Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
  2. Patients with poor lung function (FEV1% <50% or DLCO<50% predicted or home oxygen requirement) and lung lesions undergoing non-anatomic lung resection (i.e. wedge resection).
  3. Patients undergoing esophageal resection.
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Exclusion Criteria
  1. Patients with ongoing symptomatic dental infections.
  2. Patients with recent/ongoing pneumonia (<15 days from initial surgical patient evaluation).
  3. Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
  4. Patients with a preexisting tracheostomy.
  5. Age<18
  6. Patients with an allergy to Peridex/chlorhexidine solution
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Pre-operative & Post-Operative Brushing (Esophageal Resection)0.12% chlorhexidine solution* Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution * The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group.
Pre-operative & Post-Operative Brushing (Lung Resection)0.12% chlorhexidine solution* Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution * The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group.
Pre-operative brushing (Pilot Portion)0.12% chlorhexidine solution-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
Primary Outcome Measures
NameTimeMethod
Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection PatientsWithin 30 days of surgery

Patients will be considered to have postoperative pneumonia if they meet three of the following criteria within 30 days after surgery;

1. Fever (Temperature \>38.2 C)

2. Leucocytosis (WBC\>12,000/cu mm)

3. New infiltrate on chest X-ray

4. Positive sputum or bronchial culture

5. Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database.

Adherence to the Pre-operative Toothbrushing RegimenCompletion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)
Secondary Outcome Measures
NameTimeMethod
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing DiaryWithin 30 days of surgery (comparing pre-op and post-op)
Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge QuestionnaireWithin 30 days of surgery

Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire

Perioperative MortalityWithin 30 days of surgery
Postoperative Respiratory FailureWithin 30 days of surgery

Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy

Incidence of FeverWithin 24 hours of surgery

Trial Locations

Locations (1)

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

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