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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142956
• Other study ID #: soonlin0001
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: December 2, 2021

Study information

• Verified date: December 2021
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150000
• Est. completion date: December 2, 2021
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Smoking
• Wound Complication
• Wounds and Injuries

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound complications	surgical site infection and wound disruption	within 30 days after the primary procedure
Secondary	pulmonary complications	reintubation or ventilator > 48 hours	within 30 days after the primary procedure