Back to resultsPrevention of Post-operative Pneumonia (POPP) (POPP)
Primary Purpose
Post-operative Pneumonia, Lung Cancer, Esophageal Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.12% chlorhexidine solution
Sponsored by
About this trial
This is an interventional prevention trial for Post-operative Pneumonia focused on measuring Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
- 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).
- Patients undergoing esophageal resection.
Exclusion Criteria:
- Patients with ongoing symptomatic dental infections.
- Patients with recent/ongoing pneumonia (<15 days from initial surgical patient evaluation).
- Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
- Patients with a preexisting tracheostomy.
- Age<18
- Patients with an allergy to Peridex/chlorhexidine solution
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Pre-operative brushing (Pilot Portion)
Pre-operative & Post-Operative Brushing (Esophageal Resection)
Pre-operative & Post-Operative Brushing (Lung Resection)
Arm Description
-Toothbrushing 3 times/day for at least 5 days preoperatively using a 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.
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.
Outcomes
Primary Outcome Measures
Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients
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.
Adherence to the Pre-operative Toothbrushing Regimen
Secondary Outcome Measures
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary
Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire
Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire
Perioperative Mortality
Postoperative Respiratory Failure
Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy
Incidence of Fever
Full Information
NCT ID
NCT01446874
First Posted
September 30, 2011
Last Updated
October 11, 2018
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01446874
Brief Title
Prevention of Post-operative Pneumonia (POPP)
Acronym
POPP
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 Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow patient accrual and plans to perform multi-center study
Study Start Date
September 22, 2011 (Actual)
Primary Completion Date
December 13, 2015 (Actual)
Study Completion Date
December 13, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pneumonia, Lung Cancer, Esophageal Cancer
Keywords
Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-operative brushing (Pilot Portion)
Arm Type
Experimental
Arm Description
-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
Arm Title
Pre-operative & Post-Operative Brushing (Esophageal Resection)
Arm Type
Experimental
Arm 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.
Arm Title
Pre-operative & Post-Operative Brushing (Lung Resection)
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
0.12% chlorhexidine solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients
Description
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.
Time Frame
Within 30 days of surgery
Title
Adherence to the Pre-operative Toothbrushing Regimen
Time Frame
Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)
Secondary Outcome Measure Information:
Title
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary
Time Frame
Within 30 days of surgery (comparing pre-op and post-op)
Title
Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire
Description
Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire
Time Frame
Within 30 days of surgery
Title
Perioperative Mortality
Time Frame
Within 30 days of surgery
Title
Postoperative Respiratory Failure
Description
Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy
Time Frame
Within 30 days of surgery
Title
Incidence of Fever
Time Frame
Within 24 hours of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
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).
Patients undergoing esophageal resection.
Exclusion Criteria:
Patients with ongoing symptomatic dental infections.
Patients with recent/ongoing pneumonia (<15 days from initial surgical patient evaluation).
Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
Patients with a preexisting tracheostomy.
Age<18
Patients with an allergy to Peridex/chlorhexidine solution
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Varun Puri, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30291834
Citation
Semenkovich TR, Frederiksen C, Hudson JL, Subramanian M, Kollef MH, Patterson GA, Kreisel D, Meyers BF, Kozower BD, Puri V. Postoperative Pneumonia Prevention in Pulmonary Resections: A Feasibility Pilot Study. Ann Thorac Surg. 2019 Jan;107(1):262-270. doi: 10.1016/j.athoracsur.2018.08.008. Epub 2018 Oct 3.
Results Reference
derived
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
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Prevention of Post-operative Pneumonia (POPP)
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