Prevention of Post-operative Pneumonia (POPP)

NCT01446874 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 201106336
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pneumonia; Lung Cancer; Esophageal Cancer

Keywords

Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer

Outcome Measures

Primary Outcomes (2)

• 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; 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.

  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 Outcomes (5)

• 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

  Within 30 days of surgery

• Perioperative Mortality

  Within 30 days of surgery

• Postoperative Respiratory Failure

  Within 30 days of surgery

• Incidence of Fever

  Within 24 hours of surgery

Study Arms (3)

Pre-operative brushing (Pilot Portion)

EXPERIMENTAL

-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution

Drug: 0.12% chlorhexidine solution

Pre-operative & Post-Operative Brushing (Esophageal Resection)

EXPERIMENTAL

* 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

Pre-operative & Post-Operative Brushing (Lung Resection)

EXPERIMENTAL

* 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

Interventions

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.

Pre-operative & Post-Operative Brushing (Esophageal Resection); Pre-operative & Post-Operative Brushing (Lung Resection); Pre-operative brushing (Pilot Portion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
• 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).
• Patients undergoing esophageal resection.

You may not qualify if:

• Patients with ongoing symptomatic dental infections.
• Patients with recent/ongoing pneumonia (\<15 days from initial surgical patient evaluation).
• Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
• Patients with a preexisting tracheostomy.
• Age\<18
• Patients with an allergy to Peridex/chlorhexidine solution

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 30291834 DERIVED

Related Links

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

MeSH Terms

Conditions

Lung Neoplasms; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Varun Puri, M.D.
• Organization: Washington University School of Medicine

varunpuri@wustl.edu

314-362-4191

Study Officials

• Varun Puri, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 5, 2011
• Study Start: September 22, 2011
• Primary Completion: December 13, 2015
• Study Completion: December 13, 2015
• Last Updated: November 8, 2018
• Results First Posted: June 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)