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

• ClinicalTrials.gov Identifier: NCT01446874
• Recruitment Status: Terminated
• First Posted: October 5, 2011
• Results First Posted: June 12, 2018
• Last Update Posted: November 8, 2018
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Washington University School of Medicine

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 (Clinical Trial)
• 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: September 22, 2011
• Actual Primary Completion Date: December 13, 2015
• Actual Study Completion Date: December 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 [ 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) ]

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01446874
• Other Study ID Numbers: 201106336
• First Posted: October 5, 2011
• Results First Posted: June 12, 2018
• Last Update Posted: November 8, 2018
• Last Verified: October 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; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Chlorhexidine; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants