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Prevention of Post-operative Pneumonia (POPP) (POPP)

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ClinicalTrials.gov Identifier: NCT01446874
Recruitment Status : Terminated (Interim analysis showed effect size is too small)
First Posted : October 5, 2011
Results First Posted : June 12, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 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 : September 22, 2011
Actual Primary Completion Date : December 13, 2015
Actual Study Completion Date : December 13, 2015


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

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

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




Primary Outcome Measures :
  1. Number of Participants Who Develop 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;

    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.

  2. Adherence to the Pre-operative Toothbrushing Regimen [ Time Frame: Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery) ]
    -This is for pilot portion of study only


Secondary Outcome Measures :
  1. 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) ]
  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 [ Time Frame: 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 [ Time Frame: Within 30 days of surgery ]
  4. Postoperative Respiratory Failure [ Time Frame: 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 [ Time Frame: Within 24 hours of surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446874


Locations
United States, Missouri
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

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01446874     History of Changes
Other Study ID Numbers: 201106336
First Posted: October 5, 2011    Key Record Dates
Results First Posted: June 12, 2018
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
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
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pharmaceutical Solutions
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents