Prevention of Post-operative Pneumonia (POPP) (POPP)
|ClinicalTrials.gov Identifier: NCT01446874|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2011
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Pneumonia Lung Cancer Esophageal Cancer||Procedure: Intensive Brushing Regimen||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Postoperative Pneumonia (POPP Study: A Study to Evaluate the Use of a Prophylactic Clinical Strategy to Prevent Postoperative Pneumonia in Patients Undergoing Thoracic Surgery|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||June 2017|
Active Comparator: Intensive Brushing Regimen
Procedure: Intensive Brushing Regimen
Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution Intubation with tapered polyurethane cuff endotracheal tube with subglottic drainage (Mallinckrodt™ Sealguard™ Evac Endotracheal Tube, Covidien, Mansfield, MA) intraoperatively and postoperatively as indicated, based upon standard clinical practice.
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.
No Intervention: Regular brushing routine
- Incidence of postoperative pneumonia in the two groups: lung cancer resection patients and esophageal resection patients [ Time Frame: Within 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;
- Fever (Temperature >38.2 C)
- Leucocytosis (WBC>12,000/cu mm)
- New infiltrate on chest X-ray
- Positive sputum or bronchial culture
- Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database.
- Compliance with preoperative brushing and mouthwash protocol [ Time Frame: Within 30 days of surgery ]Subject compliance is measured by the subject completing a daily brushing diary, along with The Modified Morisky Medication/Intervention Adherence Scale and a Knowledge Questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446874
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|