Prevention of Post-operative Pneumonia (POPP)

The Washington University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Post-operative Pneumonia; Esophageal Cancer; Lung Cancer

Treatments: Drug: 0.12% chlorhexidine solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01446874

201106336

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Pre-operative brushing (Pilot Portion)

Experimental group

Description:

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

Treatment:

Drug: 0.12% chlorhexidine solution

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

Experimental group

Description:

* 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.

Treatment:

Drug: 0.12% chlorhexidine solution

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

Experimental group

Description:

* 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.

Treatment:

Drug: 0.12% chlorhexidine solution