Prevention of Post-operative Pneumonia (POPP)

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01446874
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Actual Duration (Months): 50.7
• Patients Per Site Per Month: 3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pneumonia; Lung Cancer; Esophageal Cancer	Drug: 0.12% chlorhexidine solution	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Sep 22, 2011
• Actual Primary Completion Date: Dec 13, 2015
• Actual Study Completion Date: Dec 13, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pre-operative brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Drug: 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.
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients [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.

2. Adherence to the Pre-operative Toothbrushing Regimen [Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)]

Secondary Outcome Measures

1. Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary [Within 30 days of surgery (comparing pre-op and post-op)]

2. Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire [Within 30 days of surgery]

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

3. Perioperative Mortality [Within 30 days of surgery]

4. Postoperative Respiratory Failure [Within 30 days of surgery]

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

5. Incidence of Fever [Within 24 hours of surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Varun Puri, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01446874
• Other Study ID Numbers: 201106336
• First Posted: Oct 5, 2011
• Last Update Posted: Nov 8, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Washington University School of Medicine: Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
• Additional relevant MeSH terms: Pneumonia; Esophageal Neoplasms; Chlorhexidine

Study Results

Participant Flow

Recruitment Details	The study opened to participant enrollment on 09/22/2011 and closed to participant enrollment on 06/08/2016.

Arm/Group Title	Pre-operative Brushing (Pilot Portion)	Pre & Post Operative Brushing (Esophageal Resection)	Pre & Post Operative Brushing (Lung Resection)
Arm/Group 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.
Period Title: Overall Study
STARTED	20	50	80
COMPLETED	18	46	62
NOT COMPLETED	2	4	18

Baseline Characteristics

Arm/Group Title	Pre-operative Brushing (Pilot Portion)	Pre-operative & Post-Operative Brushing (Esophageal Resection)	Pre-operative & Post-Operative Brushing (Lung Resection)	Total
Arm/Group 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.	Total of all reporting groups
Overall Participants	20	50	62	132
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	66	58	63	62
Sex: Female, Male (Count of Participants)
Female	7 35%	9 18%	29 46.8%	45 34.1%
Male	13 65%	41 82%	33 53.2%	87 65.9%
Region of Enrollment (Count of Participants)
United States	20 100%	50 100%	62 100%	132 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

-None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.

Arm/Group Title	Pre-operative Brushing (Pilot Portion)	Pre-operative & Post-Operative Brushing (Esophageal Resection)	Pre-operative & Post-Operative Brushing (Lung Resection)
Arm/Group 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.
Measure Participants	0	46	62
Count of Participants [Participants]	5 25%	1 2%

2. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

This outcome measure was for only the pilot portion of the study.

Arm/Group Title	Pre-operative Brushing (Pilot Portion)	Pre-operative & Post-Operative Brushing (Esophageal Resection)	Pre-operative & Post-Operative Brushing (Lung Resection)
Arm/Group 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.
Measure Participants	18	0	0
Count of Participants [Participants]	16 80%

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

The Pilot Portion is not included in this outcome measure. 3 participants in the esophageal resection group was not evaluable for this outcome measure.

Arm/Group Title	Pre-operative Brushing (Pilot Portion)	Pre-operative & Post-Operative Brushing (Esophageal Resection)	Pre-operative & Post-Operative Brushing (Lung Resection)
Arm/Group 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.
Measure Participants	0	43	62
Pre-op (compliant ≥ 80% of the time)	39 195%	50 100%
Pre-op (compliant 60-79.9% of the time)	4 20%	9 18%
Pre-op (compliant 40-59.9% of the time)	0 0%	1 2%
Pre-op (compliant ≤39.9% of the time)	0 0%	2 4%
Post-op (compliant ≥ 80% of the time)	26 130%	28 56%
Post-op (compliant 60-79.9% of the time)	3 15%	7 14%
Post-op (compliant 40-59.9% of the time)	6 30%	5 10%
Post-op (compliant ≤39.9% of the time)	8 40%	22 44%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing and the participants did not complete the questionnaire.

Arm/Group Title	Pre-operative Brushing (Pilot Portion)	Pre-operative & Post-Operative Brushing (Esophageal Resection)	Pre-operative & Post-Operative Brushing (Lung Resection)
Arm/Group 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.
Measure Participants	0	46	62
Count of Participants [Participants]	46 230%	62 124%

5. Secondary Outcome

Title	Perioperative Mortality
Time Frame	Within 30 days of surgery

Outcome Measure Data

Analysis Population Description

None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.

Arm/Group Title	Pre-operative Brushing (Pilot Portion)	Pre-operative & Post-Operative Brushing (Esophageal Resection)	Pre-operative & Post-Operative Brushing (Lung Resection)
Arm/Group 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.
Measure Participants	0	46	62
Count of Participants [Participants]	0 0%	3 6%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.

Arm/Group Title	Pre-operative Brushing (Pilot Portion)	Pre-operative & Post-Operative Brushing (Esophageal Resection)	Pre-operative & Post-Operative Brushing (Lung Resection)
Arm/Group 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.
Measure Participants	0	46	62
Bronchoscopy for atelectasis	1 5%	1 2%
Trachestomy	1 5%	1 2%
Respiratory failure	5 25%	5 10%
Reintubation	4 20%	0 0%

7. Secondary Outcome

Title	Incidence of Fever
Time Frame	Within 24 hours of surgery

Outcome Measure Data

Analysis Population Description

None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.

Arm/Group Title	Pre-operative Brushing (Pilot Portion)	Pre-operative & Post-Operative Brushing (Esophageal Resection)	Pre-operative & Post-Operative Brushing (Lung Resection)
Arm/Group 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.
Measure Participants	0	46	62
Count of Participants [Participants]	7 35%	0 0%

Adverse Events

Arm/Group Title	Pre-operative Brushing (Pilot Portion)		Pre-operative & Post-Operative Brushing (Esophageal Resection)		Pre-operative & Post-Operative Brushing (Lung Resection)
Arm/Group 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.
All Cause Mortality
	Pre-operative Brushing (Pilot Portion)		Pre-operative & Post-Operative Brushing (Esophageal Resection)		Pre-operative & Post-Operative Brushing (Lung Resection)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Pre-operative Brushing (Pilot Portion)		Pre-operative & Post-Operative Brushing (Esophageal Resection)		Pre-operative & Post-Operative Brushing (Lung Resection)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/50 (0%)		0/62 (0%)
Other (Not Including Serious) Adverse Events
	Pre-operative Brushing (Pilot Portion)		Pre-operative & Post-Operative Brushing (Esophageal Resection)		Pre-operative & Post-Operative Brushing (Lung Resection)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/50 (0%)		1/62 (1.6%)
Immune system disorders
Allergic reaction	0/20 (0%)		0/50 (0%)		1/62 (1.6%)

Limitations/Caveats

Please note that the data for this study was reanalyzed prior to submitting manuscript and the analysis showed some of the results submitted previously to clinicaltrials.gov was incorrect. The data has now been corrected in clinincaltrials.gov.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.