- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05142956
Smoking Increases the Risk of Postoperative Wound Complications: a Propensity Score-matched Cohort Study
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Taipei, Taiwan
- Taipei Medical University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Smokers
Current smokers are defined as cigarettes smoking within one year before surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
wound complications
Time Frame: within 30 days after the primary procedure
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surgical site infection and wound disruption
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within 30 days after the primary procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pulmonary complications
Time Frame: within 30 days after the primary procedure
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reintubation or ventilator > 48 hours
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within 30 days after the primary procedure
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Collaborators and Investigators
Investigators
- Study Chair: Chao-Shun Lin, PhD, Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- soonlin0001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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