NCT00889720

Brief Summary

It is possible to offer smoking cessation treatment including varenicline to patients scheduled for elective surgery. This study will evaluate whether or not this will enable some patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may lead to reductions in post-operative complication such as wound infections.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 25, 2011

Completed
Last Updated

October 17, 2011

Status Verified

July 1, 2011

Enrollment Period

8 months

First QC Date

April 28, 2009

Results QC Date

July 27, 2011

Last Update Submit

October 12, 2011

Conditions

Smoking Cessation

Keywords

smoking cessationvareniclineelective surgerywound infectionspost-operative complications

Outcome Measures

Primary Outcomes (15)

  • Percentage of Fully Compliant Participants

    Compliance defined as completed 12 weeks of varenicline therapy, underwent surgery 8 weeks +-10 days after start of varenicline treatment, and had evaluations of wound infection 1 to 3 days and 6 to 10 days after surgery.

    Baseline through Week 12

  • Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition

    Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.

    Post-surgery Days 1-3

  • Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition

    Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.

    Post-surgery Days 6-10

  • Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition

    Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.

    Week 12

  • Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition

    Surgical site infections (SSIs) assessed by 1992 CDC definition; divided into incisional and organ/space SSIs. Incisional space SSIs further classified as involving only skin and subcutaneous tissue (superficial incisional) or involving deep soft tissues (fascial and muscle layers) of the incision (deep incisional ). Organ/space SSIs involve any part of the anatomy (organs or spaces) other than incision opened or manipulated during operative procedure. None = did not have a surgical site infection. Category 0 = no surgical wound complications. Not done = not assessed.

    Week 26

  • Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection

    Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision.

    Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26

  • Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale

    Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm, c: large volume, D: prolonged \> 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.

    Post-surgery Days 1-3

  • Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale

    Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm, c: large volume, D: prolonged \> 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.

    Post-surgery Days 6-10

  • Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale

    Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm, c: large volume, D: prolonged \> 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.

    Week 12

  • Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale

    Grade 0 = normal healing (NH); Grade I = NH with (w) mild bruising (br) or haematoma (a: some br, b: considerable br, c: mild erythema); Grade II= erythema plus other signs of inflammation (a: at 1 point, b: around sutures, c: along wnd, d: around wnd); Grade III= clear or haemoserous discharge (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm, c: large volume, D: prolonged \> 3 days); Grade IV= pus (a: at 1 point only ≤ 2 cm, b: along wnd \> 2 cm; Grade V=deep or severe wnd infection (w or without tissue breakdown; haematoma requiring aspiration). Not done = not assessed.

    Week 26

  • Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3

    Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (\>40). Surgical site complication defined as total score \>10; wound infection defined as total score \>20. Not done = not assessed.

    Post-surgery Days 1-3

  • Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10

    Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (\>40). Surgical site complication defined as total score \>10; wound infection defined as total score \>20. Not done = not assessed.

    Post-surgery Days 6-10

  • Wound Healing Grade by ASEPSIS Criteria at Week 12

    Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (\>40). Surgical site complication defined as total score \>10; wound infection defined as total score \>20. Not done = not assessed.

    Week 12

  • Wound Healing Grade by ASEPSIS Criteria at Week 26

    Wound grading scale of wound characteristics assessed by portion of wound infected and point scale for daily wound inspection. Infections categorized by ASEPSIS score as satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (21-30), moderate wound infection (31-40), and severe wound infection (\>40). Surgical site complication defined as total score \>10; wound infection defined as total score \>20. Not done = not assessed.

    Week 26

  • Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission.

    Responder defined as participant who answered "No" to question on Nicotine Use Inventory (NUI), "Has the subject smoked any cigarettes or cigarillos or used any other nicotine containing products in the last 7 days?" Additionally, responder status confirmed by measurement of end-expiratory exhaled carbon monoxide concentration \<10 parts per million (ppm).

    7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)

Secondary Outcomes (7)

  • Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System

    Baseline through Week 26

  • Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline.

    Baseline, Week 8

  • Number of Participants With 7-day Point Prevalence (PP) for Abstinence From Cigarette Smoking and Other Nicotine Use at the End of Treatment (Week 12)

    Week 12

  • Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26

    Week 26

  • Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline.

    Baseline, Week 12, Week 26

  • +2 more secondary outcomes

Study Arms (1)

Smoking cessation tratment including varenicline

OTHER
Drug: Varenicline

Interventions

VareniclineDRUG

Varenicline film coated tablets - escalating dose with maximum dose of 1mg bd

Also known as: Champix
Smoking cessation tratment including varenicline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokers motivated to stop smoking scheduled for elective surgery

You may not qualify if:

  • Current or recent depression
  • Current or recent suicidal ideation
  • Uncontrolled or unstable clinically significant medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Paris, 75651, France

Location

Pfizer Investigational Site

Pisa, 56124, Italy

Location

Related Links

MeSH Terms

Conditions

Smoking CessationWound Infection

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorInfections

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Limitations and Caveats

This study was terminated after 16 of 100 planned subjects were enrolled due to slow recruitment and non-compliance with the protocol; only selected efficacy listings of the surgical population and key safety data were reported.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

November 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 17, 2011

Results First Posted

August 25, 2011

Record last verified: 2011-07

Locations

IT(1)FR(1)