A Multicenter, Open Label Study To Investigate The Feasibility And Efficacy Of A Smoking Cessation Program With Varenicline In Patients Undergoing Elective Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of Fully Compliant Participants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smokers motivated to stop smoking scheduled for elective surgery
排除标准
- •Current or recent depression
- •Current or recent suicidal ideation
- •Uncontrolled or unstable clinically significant medical condition
研究组 & 干预措施
Smoking cessation tratment including varenicline
干预措施: Varenicline (Drug)
结局指标
主要结局
Percentage of Fully Compliant Participants
时间窗: 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
时间窗: 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.
Wound Healing Grade by ASEPSIS Criteria: Post-surgery Days 6 to 10
时间窗: 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.
Number of Participants With Surgical Site Infection Post-surgery Days 6 to 10: Center for Disease Control (CDC) Definition
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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 at Week 12
时间窗: 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
时间窗: 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.
时间窗: 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).
次要结局
- 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)
- 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))
- Number of Treatment Emergent Adverse Events by Severity(Baseline through Week 26 (within 30 days of last dose))