Clinical trial NCT05142956: Smoking Increases the Risk of Postoperative Wound Complications: a Propensity Score-matched Cohort Study
Official title: Smoking Increases the Risk of Postoperative Wound Complications: a Propensity Score-matched Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Complication
Smoking
Postoperative Complications
Keywords: Smoking; Postoperative wound complications
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 1150000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical cases from 2013-2018 NSQIP dataset

Brief summary: Cigarette smoking is associated with surgical complications, including wound healing and surgical site infection. However, the association between smoking status and postoperative wound complications is not completely understood. Our objective is to investigate the effect of smoking on postoperative wound complications for major surgeries.

Detailed description: Smoking at the time of surgery is recognized as a risk factor for cardiovascular, respiratory, and wound-related perioperative complications. Wound-related complications can prolong hospital stays, increase hospital resource utilization, and pose an obvious threat to patient recovery. A brief statement on perioperative smoking cessation about smoking impacting wound healing was published by the American Society of Anesthesiologists' Task Force on Smoking Cessation. Recently, a consensus statement on perioperative smoking cessation by Society for Perioperative Assessment and Quality Improvement (SPAQI) mentioned that smoking cessation should be done as soon as practicable with surgical scheduling. More extended abstinence is associated with lower rates of wound healing complications.

Several studies have described smoking harms wound healing in specific operations, such as plastic surgery, breast surgery, gastrointestinal surgery, and hip surgery. They found surgical site infection and wound delayed healing more frequently in smokers. But in a few small studies and some surgery, conflicting results were found. Besides, risk factors associated with wound complications include infection, smoking, aging, malnutrition, immobilization, diabetes, vascular disease, and immunosuppressive therapy.

This study aims to determine the impact of smoking on wound complications for all kinds of major surgeries. To clarify the risks, our study uses the updated National Surgical Quality Improvement Program (NSQIP) database to find if patients who were active smokers are more likely to have wound-related complications postoperatively. We hypothesized that the active smoking population will have increased infectious complications and wound dehiscence compared with the nonsmoking population.

Eligibility criteria: Inclusion Criteria:

* From NSQIP dataset, patients with complete information for baseline parameters and without preoperative open wound infections

Exclusion Criteria:

* Incomplete information of baseline parameters, and with preoperative wound infection

Primary outcomes:
measure: wound complications
timeFrame: within 30 days after the primary procedure
Secondary outcomes:
measure: pulmonary complications
timeFrame: within 30 days after the primary procedure
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
name: Chao-Shun Lin, PhD
role: STUDY_CHAIR
References: