Prevention of Post-operative Pneumonia (POPP) (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.

Study Overview

• Status: Terminated
• Conditions: Esophageal Cancer; Lung Cancer; Post-operative Pneumonia
• Intervention / Treatment: Drug: 0.12% chlorhexidine solution

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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; Fever (Temperature >38.2 C); Leucocytosis (WBC>12,000/cu mm); New infiltrate on chest X-ray; Positive sputum or bronchial culture; Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database.	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Varun Puri, M.D., Washington University School of Medicine

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2011
• Primary Completion (Actual): December 13, 2015
• Study Completion (Actual): December 13, 2015

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: October 4, 2011
• First Posted (Estimate): October 5, 2011

Study Record Updates

• Last Update Posted (Actual): November 8, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Pneumonia; Esophageal Neoplasms; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 201106336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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