ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01446874
Recruitment Status : Terminated (Slow patient accrual and plans to perform multi-center study)
First Posted : October 5, 2011
Results First Posted : June 12, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

September 30, 2011
October 5, 2011
March 15, 2018
June 12, 2018
November 8, 2018
September 22, 2011
December 13, 2015   (Final data collection date for primary outcome measure)
  • 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.
  • Adherence to the Pre-operative Toothbrushing Regimen [ Time Frame: Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery) ]
Incidence of 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;
  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.
Complete list of historical versions of study NCT01446874 on ClinicalTrials.gov Archive Site
  • 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) ]
  • 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
  • Perioperative Mortality [ Time Frame: Within 30 days of surgery ]
  • 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
  • Incidence of Fever [ Time Frame: Within 24 hours of surgery ]
Compliance with preoperative brushing and mouthwash protocol
Subject compliance is measured by the subject completing a daily brushing diary, along with The Modified Morisky Medication/Intervention Adherence Scale and a Knowledge Questionnaire.
Not Provided
Not Provided
 
Prevention of Post-operative Pneumonia (POPP)
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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Post-operative Pneumonia
  • Lung Cancer
  • Esophageal Cancer
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 brushing (Pilot Portion)
    -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
    Intervention: Drug: 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.
    Intervention: Drug: 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.
    Intervention: Drug: 0.12% chlorhexidine solution
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. 2018 Oct 3. pii: S0003-4975(18)31350-X. doi: 10.1016/j.athoracsur.2018.08.008. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
330
December 13, 2015
December 13, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01446874
201106336
Yes
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
Plan to Share IPD: No
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Varun Puri, M.D. Washington University School of Medicine
Washington University School of Medicine
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP