A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00889720
First received: April 28, 2009
Last updated: October 12, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: Varenicline
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label Study To Investigate The Feasibility And Efficacy Of A Smoking Cessation Program With Varenicline In Patients Undergoing Elective Surgery

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Fully Compliant Participants [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition [ Time Frame: Post-surgery Days 1-3 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition [ Time Frame: Post-surgery Days 6-10 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Surgical Site Infections With Microbiological Confirmation of Bacterial Infection [ Time Frame: Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26 ] [ Designated as safety issue: No ]
    Microbiological confirmation defined as organisms isolated from an aseptically obtained culture of fluid or tissues from the superficial incision.

  • Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale [ Time Frame: Post-surgery Days 1-3 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale [ Time Frame: Post-surgery Days 6-10 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.

  • Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3 [ Time Frame: Post-surgery Days 1-3 ] [ Designated as safety issue: No ]
    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.

  • Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10 [ Time Frame: Post-surgery Days 6-10 ] [ Designated as safety issue: No ]
    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.

  • Wound Healing Grade by ASEPSIS Criteria at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.

  • Wound Healing Grade by ASEPSIS Criteria at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission. [ Time Frame: 7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System [ Time Frame: Baseline through Week 26 ] [ Designated as safety issue: No ]
    Grade 0: no post-operative (post-op) complications (comp), Grade 1: any deviation from normal post-op course without need for pharmacological treatment (PT) other than allowed interventions (INT), or surgical, endoscopic or radiological INT; Grade II: required PT with drugs other than those allowed for grade I comp; Grade III required surgical, endoscopic or radiological INT, IIIa: not under general anaesthesia (GA), IIIb: under GA; Grade IV: life-threatening comp requiring IC/ICU management, IVa: single organ dysfunction (DSF), IVb: multiorgan DSF; Grade V: death. Not done = not assessed.

  • Percentage of Participants Who Succeed in Reducing Their Cigarette Consumption by at Least 50% in 7 Days Preceding Hospital Admission Compared With Baseline. [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants Who Reduced Their Cigarette Consumption by at Least 50% in the 7 Days Preceding Weeks 12 and 26 Compared With Baseline. [ Time Frame: Baseline, Week 12, Week 26 ] [ Designated as safety issue: No ]
  • Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline [ Time Frame: Baseline through Week 26 (within 30 days of last dose) ] [ Designated as safety issue: Yes ]
    Treatment-emergent AE (TEAE): any untoward medical occurrence that occurred or worsened after beginning study treatment without regard to causal relationship. Treatment-related TEAE: investigator assessment of reasonable possibility that treatment caused or contributed to AE. Severe TEAE: interfered significantly with usual function. SAE: AE resulting in death, initial or prolonged inpatient hospitalization, a life-threatening experience (immediate risk of death), persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason.

  • Number of Treatment Emergent Adverse Events by Severity [ Time Frame: Baseline through Week 26 (within 30 days of last dose) ] [ Designated as safety issue: No ]
    Mild: did not interfere with usual function; Moderate: interfered to some extent with usual function; Severe: interfered significantly with usual function. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the most severe occurrence was taken. Missing baseline severities were imputed as mild.


Enrollment: 16
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Smoking cessation tratment including varenicline Drug: Varenicline
Varenicline film coated tablets - escalating dose with maximum dose of 1mg bd
Other Name: Champix

Detailed Description:

Recruitment to this study was terminated (on February 23, 2010) earlier than originally planned because recruitment was much slower than expected and therefore the study has already achieved its main objective of assessing the feasibility of conducting a larger study of similar design to investigate the efficacy of smoking cessation therapy in a pre-surgical setting. The decision to end recruitment to the trial was not based on any safety concerns.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smokers motivated to stop smoking scheduled for elective surgery

Exclusion Criteria:

  • Current or recent depression
  • Current or recent suicidal ideation
  • Uncontrolled or unstable clinically significant medical condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889720

Locations
France
Pfizer Investigational Site
Paris Cedex 13, France, 75651
Italy
Pfizer Investigational Site
Pisa, Italy, 56124
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00889720     History of Changes
Other Study ID Numbers: A3051113
Study First Received: April 28, 2009
Results First Received: July 27, 2011
Last Updated: October 12, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Pfizer:
smoking cessation
varenicline
elective surgery
wound infections
post-operative complications

Additional relevant MeSH terms:
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014