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CompletedNCT05142956Updated Dec 3, 2021

Smoking Increases the Risk of Postoperative Wound Complications: a Propensity Score-matched Cohort Study

An observational study in Wound Complication, Smoking and Postoperative Complications, sponsored by Taipei Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-03.

Sponsored by Taipei Medical University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,150,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Wound Complication
  • Smoking
  • Postoperative Complications

Keywords

  • Smoking; Postoperative wound complications
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's enrollment of 1,150,000 is above the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Taipei Medical University Hospital is the lead sponsor of 62 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Surgical cases from 2013-2018 NSQIP dataset

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Incomplete information of baseline parameters, and with preoperative wound infection
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,150,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Smokers

    Current smokers are defined as cigarettes smoking within one year before surgery.

06

What researchers measure

Primary outcomes

  1. wound complications

    surgical site infection and wound disruption

    Time frame: within 30 days after the primary procedure

Secondary outcomes

  1. pulmonary complications

    reintubation or ventilator \> 48 hours

    Time frame: within 30 days after the primary procedure

07

Study locations

1 site
  • Taipei Medical University Hospital
    Taipei, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05142956
Lead sponsor
Taipei Medical University Hospital
Responsible party
Chao-Shun Lin (Attending physician of anesthesiology, clinical professor, Taipei Medical University Hospital) — Principal investigator
First posted
Dec 3, 2021
Start date
Oct 1, 2021
Primary completion
Nov 28, 2021
Completion
Dec 2, 2021
Last update
Dec 3, 2021

Study contacts

Chao-Shun Lin, PhD
study chair · Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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