Trial Outcomes & Findings for Prevention of Post-operative Pneumonia (POPP) (NCT NCT01446874)

NCT ID: NCT01446874

Last Updated: 2018-11-08

Results Overview

Patients will be considered to have postoperative pneumonia if they meet three of the following criteria within 30 days after surgery; 1. Fever (Temperature \>38.2 C) 2. Leucocytosis (WBC\>12,000/cu mm) 3. New infiltrate on chest X-ray 4. Positive sputum or bronchial culture 5. Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 150 participants
• Primary outcome timeframe: Within 30 days of surgery
• Results posted on: 2018-11-08

Participant Flow

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

Participant milestones

Measure	Pre-operative Brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre & 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.	Pre & 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.
Overall Study STARTED	20	50	80
Overall Study COMPLETED	18	46	62
Overall Study NOT COMPLETED	2	4	18

Reasons for withdrawal

Measure	Pre-operative Brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre & 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.	Pre & 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.
Overall Study Not eligible	1	0	0
Overall Study No surgery/No qualifying surgery	1	0	12
Overall Study Non-compliance	0	4	0
Overall Study Antibiotics for pre-op infection	0	0	2
Overall Study Withdrawal by Subject	0	0	4

Baseline Characteristics

Prevention of Post-operative Pneumonia (POPP)

Baseline characteristics by cohort

Measure	Pre-operative Brushing (Pilot Portion) n=20 Participants -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre-operative & Post-Operative Brushing (Esophageal Resection) n=50 Participants * 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.	Pre-operative & Post-Operative Brushing (Lung Resection) n=62 Participants * 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 n=132 Participants Total of all reporting groups
Age, Continuous	66 years n=5 Participants	58 years n=7 Participants	63 years n=5 Participants	62 years n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	29 Participants n=5 Participants	45 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	41 Participants n=7 Participants	33 Participants n=5 Participants	87 Participants n=4 Participants
Region of Enrollment United States	20 Participants n=5 Participants	50 Participants n=7 Participants	62 Participants n=5 Participants	132 Participants n=4 Participants

PRIMARY outcome

Timeframe: Within 30 days of surgery

Population: -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.

Patients will be considered to have postoperative pneumonia if they meet three of the following criteria within 30 days after surgery;

1. Fever (Temperature >38.2 C)

2. Leucocytosis (WBC>12,000/cu mm)

3. New infiltrate on chest X-ray

4. Positive sputum or bronchial culture

5. Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database.

Outcome measures

Measure	Pre-operative Brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre-operative & Post-Operative Brushing (Esophageal Resection) n=46 Participants * 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.	Pre-operative & Post-Operative Brushing (Lung Resection) n=62 Participants * 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.
Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients	—	5 Participants	1 Participants

PRIMARY outcome

Timeframe: Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)

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

Outcome measures

Measure	Pre-operative Brushing (Pilot Portion) n=18 Participants -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	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.	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.
Adherence to the Pre-operative Toothbrushing Regimen	16 Participants	—	—

SECONDARY outcome

Timeframe: Within 30 days of surgery (comparing pre-op and post-op)

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

Outcome measures

Measure	Pre-operative Brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre-operative & Post-Operative Brushing (Esophageal Resection) n=43 Participants * 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.	Pre-operative & Post-Operative Brushing (Lung Resection) n=62 Participants * 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.
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary Pre-op (compliant ≥ 80% of the time)	—	39 Participants	50 Participants
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary Pre-op (compliant 60-79.9% of the time)	—	4 Participants	9 Participants
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary Pre-op (compliant 40-59.9% of the time)	—	0 Participants	1 Participants
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary Pre-op (compliant ≤39.9% of the time)	—	0 Participants	2 Participants
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary Post-op (compliant ≥ 80% of the time)	—	26 Participants	28 Participants
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary Post-op (compliant 60-79.9% of the time)	—	3 Participants	7 Participants
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary Post-op (compliant 40-59.9% of the time)	—	6 Participants	5 Participants
Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary Post-op (compliant ≤39.9% of the time)	—	8 Participants	22 Participants

SECONDARY outcome

Timeframe: Within 30 days of surgery

Population: 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.

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

Outcome measures

Measure	Pre-operative Brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre-operative & Post-Operative Brushing (Esophageal Resection) n=46 Participants * 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.	Pre-operative & Post-Operative Brushing (Lung Resection) n=62 Participants * 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.
Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire	—	46 Participants	62 Participants

SECONDARY outcome

Timeframe: Within 30 days of surgery

Population: 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.

Outcome measures

Measure	Pre-operative Brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre-operative & Post-Operative Brushing (Esophageal Resection) n=46 Participants * 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.	Pre-operative & Post-Operative Brushing (Lung Resection) n=62 Participants * 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.
Perioperative Mortality	—	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Within 30 days of surgery

Population: 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.

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

Outcome measures

Measure	Pre-operative Brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre-operative & Post-Operative Brushing (Esophageal Resection) n=46 Participants * 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.	Pre-operative & Post-Operative Brushing (Lung Resection) n=62 Participants * 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.
Postoperative Respiratory Failure Bronchoscopy for atelectasis	—	1 Participants	1 Participants
Postoperative Respiratory Failure Trachestomy	—	1 Participants	1 Participants
Postoperative Respiratory Failure Respiratory failure	—	5 Participants	5 Participants
Postoperative Respiratory Failure Reintubation	—	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 24 hours of surgery

Population: 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.

Outcome measures

Measure	Pre-operative Brushing (Pilot Portion) -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre-operative & Post-Operative Brushing (Esophageal Resection) n=46 Participants * 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.	Pre-operative & Post-Operative Brushing (Lung Resection) n=62 Participants * 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.
Incidence of Fever	—	7 Participants	0 Participants

Adverse Events

Pre-operative Brushing (Pilot Portion)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pre-operative Brushing (Pilot Portion) n=20 participants at risk -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution	Pre-operative & Post-Operative Brushing (Esophageal Resection) n=50 participants at risk * 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.	Pre-operative & Post-Operative Brushing (Lung Resection) n=62 participants at risk * 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.
Immune system disorders Allergic reaction	0.00% 0/20	0.00% 0/50	1.6% 1/62

Additional Information

Varun Puri, M.D.

Washington University School of Medicine

Phone: 314-362-4191

Email: varunpuri@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place