Post-operative PneumoniaPhase 2/3POPPNCT01446874
Prevention of Post-operative Pneumonia (POPP)
A Phase 2/3 study testing 0.12% chlorhexidine solution in people with Post-operative Pneumonia and Lung Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pneumonia, Lung Cancer, Esophageal Cancer
- What is being tested?
- 0.12% chlorhexidine solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2011to 13 Dec 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
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
- Being tested
- 0.12% chlorhexidine solution
- Keywords
- Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
- Medical subject headings
- Lung Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.12% chlorhexidine solutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative brushing (Pilot Portion) | Experimental | -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution Receives: 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. Receives: 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. Receives: Drug: 0.12% chlorhexidine solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days of surgery
Adherence to the Pre-operative Toothbrushing Regimen
Measured: 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
Measured: 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
Measured: Within 30 days of surgery
Perioperative Mortality
Measured: Within 30 days of surgery
Postoperative Respiratory Failure
Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy
Measured: Within 30 days of surgery
Incidence of Fever
Measured: Within 24 hours of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study start22 Sep 2011
- Primary completion13 Dec 2015
- Study completion13 Dec 2015
Why it stopped: Slow patient accrual and plans to perform multi-center study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PneumoniaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Varun Puri, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446874
- Sponsor's protocol ID
- 201106336
- Acronym
- POPP
- Status last verified
- Oct 2018
- First submitted
- 30 Sep 2011
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30291834
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01446874
- Acronym / sponsor ID
- POPP / 201106336
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow patient accrual and plans to perform multi-center study
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 22 Sep 2011 (actual)
- Primary completion
- 13 Dec 2015 (actual)
- Study completion
- 13 Dec 2015 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Posted 12 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-operative brushing (Pilot Portion) | Experimental | Drug: 0.12% chlorhexidine solution-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution |
| Pre-operative & Post-Operative Brushing (Esophageal Resection) | Experimental | Drug: 0.12% chlorhexidine solution* 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. |
| Pre-operative & Post-Operative Brushing (Lung Resection) | Experimental | Drug: 0.12% chlorhexidine solution* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.12% chlorhexidine solutionToothbrushing 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. | Drug | Pre-operative & Post-Operative Brushing (Esophageal Resection), Pre-operative & Post-Operative Brushing (Lung Resection), Pre-operative brushing (Pilot Portion) |
Primary outcome
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)
5 secondary outcomes
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
Perioperative Mortality
Time frame: Within 30 days of surgery
Postoperative Respiratory Failure
Time frame: Within 30 days of surgery
Incidence of Fever
Time frame: Within 24 hours of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30291834Semenkovich 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.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varun Puri, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 0.12% chlorhexidine solution in people with Post-operative Pneumonia and Lung Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01446874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.