Prevention of Post-operative Pneumonia (POPP)

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-22

Study Completion Date

2015-12-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-operative Pneumonia Lung Cancer Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pre-operative brushing (Pilot Portion)

-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution

Group Type EXPERIMENTAL

0.12% chlorhexidine solution

Intervention Type DRUG

Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.

Pre-operative & Post-Operative Brushing (Esophageal Resection)

* 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.

Group Type EXPERIMENTAL

0.12% chlorhexidine solution

Intervention Type DRUG

Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.

Pre-operative & Post-Operative Brushing (Lung Resection)

* 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.

Group Type EXPERIMENTAL

0.12% chlorhexidine solution

Intervention Type DRUG

Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.

Interventions

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0.12% chlorhexidine solution

Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.

Intervention Type DRUG

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No