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Slow patient accrual and plans to perform multi-center study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-operative brushing (Pilot Portion) | Experimental | -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution |
|
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Experimental |
|
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| Pre-operative & Post-Operative Brushing (Lung Resection) | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.12% chlorhexidine solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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;
| Within 30 days of surgery |
| Adherence to the Pre-operative Toothbrushing Regimen | Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | Within 30 days of surgery (comparing pre-op and post-op) | |
| Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Varun Puri, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30291834 | Derived | 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. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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The study opened to participant enrollment on 09/22/2011 and closed to participant enrollment on 06/08/2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-operative Brushing (Pilot Portion) | -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution |
| FG001 | Pre & Post Operative Brushing (Esophageal Resection) |
|
| FG002 | Pre & Post Operative Brushing (Lung Resection) |
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-operative Brushing (Pilot Portion) | -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution |
| BG001 | Pre-operative & Post-Operative Brushing (Esophageal Resection) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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;
| -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. | Posted | Count of Participants | Participants | Within 30 days of surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-operative Brushing (Pilot Portion) | -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Varun Puri, M.D. | Washington University School of Medicine | 314-362-4191 | varunpuri@wustl.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire |
| Within 30 days of surgery |
| Perioperative Mortality | Within 30 days of surgery |
| Postoperative Respiratory Failure | Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy | Within 30 days of surgery |
| Incidence of Fever | Within 24 hours of surgery |
| Non-compliance |
|
| Antibiotics for pre-op infection |
|
| Withdrawal by Subject |
|
| BG002 | Pre-operative & Post-Operative Brushing (Lung Resection) |
|
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Pre-operative & Post-Operative Brushing (Esophageal Resection) |
|
| OG002 | Pre-operative & Post-Operative Brushing (Lung Resection) |
|
|
|
| Primary | Adherence to the Pre-operative Toothbrushing Regimen | This outcome measure was for only the pilot portion of the study. | Posted | Count of Participants | Participants | Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery) |
|
|
|
| Secondary | Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary | The Pilot Portion is not included in this outcome measure. 3 participants in the esophageal resection group was not evaluable for this outcome measure. | Posted | Count of Participants | Participants | Within 30 days of surgery (comparing pre-op and post-op) |
|
|
|
| Secondary | 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 | 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. | Posted | Count of Participants | Participants | Within 30 days of surgery |
|
|
|
| Secondary | Perioperative Mortality | 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. | Posted | Count of Participants | Participants | Within 30 days of surgery |
|
|
|
| Secondary | Postoperative Respiratory Failure | Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy | 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. | Posted | Count of Participants | Participants | Within 30 days of surgery |
|
|
|
| Secondary | Incidence of Fever | 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. | Posted | Count of Participants | Participants | Within 24 hours of surgery |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Pre-operative & Post-Operative Brushing (Esophageal Resection) |
| 0 | 50 | 0 | 50 |
| EG002 | Pre-operative & Post-Operative Brushing (Lung Resection) |
| 0 | 62 | 1 | 62 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| Pre-op (compliant 40-59.9% of the time) |
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| Pre-op (compliant ≤39.9% of the time) |
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| Post-op (compliant ≥ 80% of the time) |
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| Post-op (compliant 60-79.9% of the time) |
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| Post-op (compliant 40-59.9% of the time) |
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| Post-op (compliant ≤39.9% of the time) |
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| Respiratory failure |
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| Reintubation |
|