Smoking Cessation
Conditions
Keywords
smoking cessation, varenicline, elective surgery, wound infections, post-operative complications
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.
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.
Interventions
DRUGVarenicline
Varenicline film coated tablets - escalating dose with maximum dose of 1mg bd
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Fully Compliant Participants | Baseline through Week 12 | 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 | Post-surgery Days 1-3 | 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 | Post-surgery Days 6-10 | 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 | Week 12 | 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 | Week 26 | 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 | Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26 | 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 | Post-surgery Days 1-3 | 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 | Post-surgery Days 6-10 | 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 | Week 12 | 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 | Week 26 | 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 | Post-surgery Days 1-3 | 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. |
| Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10 | Post-surgery Days 6-10 | 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. |
| Wound Healing Grade by ASEPSIS Criteria at Week 12 | 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. |
| Wound Healing Grade by ASEPSIS Criteria at Week 26 | 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. |
| Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission. | 7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | Baseline through Week 26 | 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. | 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 | 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 | Week 26 | 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. | Baseline, Week 12, Week 26 | — |
| Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline | Baseline through Week 26 (within 30 days of last dose) | 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 | Baseline through Week 26 (within 30 days of last dose) | 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. |
Countries
France, Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Varenicline Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Varenicline |
|---|---|
| Age, Customized >= 65 years | 3 Participants |
| Age, Customized Between 18 and 44 years | 6 Participants |
| Age, Customized Between 45 and 64 years | 7 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
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).
Time frame: 7 days prior to hospital admission to day of hospital admission (after Week 8 of treatment)
Population: Surgical population: N = participants who took at least 1 dose of study medication and received planned surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Number of Participants With 7 Day Point Prevalence (PP) for Smoking Abstinence Prior to Hospital Admission. | 9 participants |
Primary
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.
Time frame: Week 12
Population: Surgical Population; N= number of participants with a Week 12 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale | Grade 0 | 8 participants |
| Varenicline | Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale | Grade Ia | 1 participants |
| Varenicline | Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 12: Southampton Wound Assessment Scale | Not done | 2 participants |
Primary
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.
Time frame: Week 26
Population: Surgical Population; N= number of participants with a Week 26 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale | Grade 0 | 8 participants |
| Varenicline | Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections at Week 26: Southampton Wound Assessment Scale | Not done | 1 participants |
Primary
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.
Time frame: Post-surgery Days 1-3
Population: Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | 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 | 10 participants |
| Varenicline | 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 Ia | 1 participants |
| Varenicline | Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 1 to 3: Southampton Wound Assessment Scale | Not done | 1 participants |
Primary
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.
Time frame: Post-surgery Days 6-10
Population: Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | 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 | 8 participants |
| Varenicline | 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 Ia | 1 participants |
| Varenicline | 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 IIa | 1 participants |
| Varenicline | 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 IIb | 1 participants |
| Varenicline | Number of Participants With Grade of Wound Healing and Severity of Surgical Site Infections Post-surgery Days 6 to 10: Southampton Wound Assessment Scale | Not done | 1 participants |
Primary
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.
Time frame: Week 12
Population: Surgical Population; N= number of participants with a Week 12 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition | Category 0: no surgical wound complications | 9 participants |
| Varenicline | Number of Participants With Surgical Site Infection at Week 12: Center for Disease Control (CDC) Definition | Not done | 2 participants |
Primary
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.
Time frame: Week 26
Population: Surgical Population; N= number of participants with a Week 26 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition | Category 0: no surgical wound complications | 9 participants |
| Varenicline | Number of Participants With Surgical Site Infection at Week 26: Center for Disease Control (CDC) Definition | Not done | 0 participants |
Primary
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.
Time frame: Post-surgery Days 1-3
Population: Surgical Population; N= number of participants with a Day 1-3 post-surgery visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition | Category 0: no surgical wound complications | 11 participants |
| Varenicline | Number of Participants With Surgical Site Infection Post-surgery Days 1 to 3: Center for Disease Control (CDC) Definition | Not done | 1 participants |
Primary
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.
Time frame: Post-surgery Days 6-10
Population: Surgical Population; N= number of participants with a Day 6-10 post-surgery visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition | Category 0: no surgical wound complications | 11 participants |
| Varenicline | Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition | Not Done | 1 participants |
Primary
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.
Time frame: Post-surgery Days 1-3, Post-surgery Days 6-10, Week 12, Week 26
Population: Surgical Population; Due to satisfactory wound healing in all subjects, microbiological assessment was not necessary and no swabs were taken.
Primary
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.
Time frame: Baseline through Week 12
Population: Surgical Population: subset of Full Analysis Set; includes all participants who took at least 1 dose (including partial doses) of study medication and received their planned surgery within the study period. N = participants in surgical population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Percentage of Fully Compliant Participants | 0 percentage of participants |
Primary
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.
Time frame: Week 12
Population: Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 12 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Wound Healing Grade by ASEPSIS Criteria at Week 12 | Satisfactory healing | 6 participants |
| Varenicline | Wound Healing Grade by ASEPSIS Criteria at Week 12 | Not done | 1 participants |
Primary
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.
Time frame: Week 26
Population: Surgical Population; N = number of participants who had ASEPSIS wound grading during the study and had a Week 24 visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Wound Healing Grade by ASEPSIS Criteria at Week 26 | Satisfactory healing | 6 participants |
| Varenicline | Wound Healing Grade by ASEPSIS Criteria at Week 26 | Not done | 0 participants |
Primary
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.
Time frame: Post-surgery Days 1-3
Population: Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 1-3 post-surgery visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3 | Satisfactory healing | 7 participants |
| Varenicline | Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 1 to 3 | Not done | 1 participants |
Primary
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.
Time frame: Post-surgery Days 6-10
Population: Surgical Population; N= number of participants who had ASEPSIS wound grading during the study and had a Day 6-10 post-surgery visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10 | Satisfactory healing | 7 participants |
| Varenicline | Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10 | Not done | 1 participants |
Secondary
Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System
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.
Time frame: Baseline through Week 26
Population: Surgical Population; N = participants who took at least 1 dose of study medication and received planned surgery. Results provided for participants who had a study visit at timepoint. For participants with more than 1 incidence of surgical complication recorded, the most severe incidence was used for analysis. Abbreviations: PS=post-surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | 1-3 days PS: No post-operative complications | 10 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | 1-3 days PS: Grade II | 1 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | 1-3 days PS: Not done | 1 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | 6-10 days PS: No post-operative complications | 7 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | 6-10 days PS: Grade I | 3 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | 6-10 days PS: Grade II | 1 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | 6-10 days PS: Not done | 1 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | Week 12: No post-operative complications | 7 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | Week 12: Grade II | 1 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | Week 12: Grade IIIb | 1 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | Week 12: Not done | 2 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | Week 26: No post-operative complications | 8 participants |
| Varenicline | Number of Participants by Severity of Post-operative Complications: Dindo, Demartines and Clavien Classification System | Week 26: Grade IIIb | 1 participants |
Secondary
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)
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).
Time frame: Week 12
Population: Surgical population: N = number of participants who had a Week 12 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | 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) | 9 participants |
Secondary
Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26
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).
Time frame: Week 26
Population: Surgical population: N = number of participants who had a Week 26 visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Varenicline | Number of Participants With 7 Day Point Prevalence (PP) for Abstinence in the Week Preceding Week 26 | 7 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline
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.
Time frame: Baseline through Week 26 (within 30 days of last dose)
Population: Safety analysis set: participants who took at least 1 dose (including partial doses) of study medication. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline | TEAE: all causalities | 9 participants |
| Varenicline | Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline | TEAE: treatment-related | 8 participants |
| Varenicline | Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline | Severe TEAE: all causalities | 3 participants |
| Varenicline | Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline | Severe TEAE: treatment-related | 1 participants |
| Varenicline | Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline | SAE: all causalities | 1 participants |
| Varenicline | Number of Participants With Treatment-Emergent Adverse Events by Type, Severity, Seriousness, and Relatedness to Varenicline | SAE: treatment-related | 0 participants |
Secondary
Number of Treatment Emergent Adverse Events by Severity
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.
Time frame: Baseline through Week 26 (within 30 days of last dose)
Population: Safety analysis set. N = number of treated subjects. Includes data up to 30 days after last dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Varenicline | Number of Treatment Emergent Adverse Events by Severity | Mild | 13 events |
| Varenicline | Number of Treatment Emergent Adverse Events by Severity | Moderate | 11 events |
| Varenicline | Number of Treatment Emergent Adverse Events by Severity | Severe | 4 events |
Secondary
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
Population: Surgical population: Not analyzed due the limited number of participants recruited.
Secondary
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
Population: Surgical population. Not analyzed due the limited number of participants recruited.