Wound ComplicationNCT05142956
Smoking Increases the Risk of Postoperative Wound Complications: a Propensity Score-matched Cohort Study
An observational study of Wound Complication and Smoking, run by Taipei Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Complication, Smoking, Postoperative Complications
- How many people
- 1,150,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2021to 2 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical cases from 2013-2018 NSQIP dataset
Who may be able to join
- From NSQIP dataset, patients with complete information for baseline parameters and without preoperative open wound infections
Who cannot join
- Incomplete information of baseline parameters, and with preoperative wound infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Wound Complication, Smoking, Postoperative Complications
- Keywords
- Smoking; Postoperative wound complications
- Medical subject headings
- Smoking, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Current smokers are defined as cigarettes smoking within one year before surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound complications
surgical site infection and wound disruption
Measured: within 30 days after the primary procedure
Secondary outcomes (1)
pulmonary complications
reintubation or ventilator > 48 hours
Measured: within 30 days after the primary procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Oct 2021
- Primary completion28 Nov 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,150,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao-Shun Lin, Taipei Medical University Hospital
- Investigators
- Chao-Shun Lin, PhD, Study chair, Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142956
- Sponsor's protocol ID
- soonlin0001
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Increases the Risk of Postoperative Wound Complications: a Propensity Score-matched Cohort Study
- ClinicalTrials.gov ID
- NCT05142956
- Acronym / sponsor ID
- soonlin0001
- Conditions
- Wound Complication, Smoking, Postoperative Complications
- Keywords
- Smoking; Postoperative wound complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,150,000 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Nov 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers | – | –Current smokers are defined as cigarettes smoking within one year before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical cases from 2013-2018 NSQIP dataset
Key inclusion criteria (1 listed)
- From NSQIP dataset, patients with complete information for baseline parameters and without preoperative open wound infections
Key exclusion criteria (1 listed)
- Incomplete information of baseline parameters, and with preoperative wound infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
wound complications
Time frame: within 30 days after the primary procedure
surgical site infection and wound disruption
1 secondary outcome
pulmonary complications
Time frame: within 30 days after the primary procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao-Shun Lin, PhD study chair
Department of Anesthesiology, Taipei Medical University Hospital, 252 Wuxing St., Taipei 110 Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Complication and Smoking, run by Taipei Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound complications (time frame: within 30 days after the primary procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.