Coronary Artery Bypass GraftNCT01629030
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
An observational study of Coronary Artery Bypass Graft and Median Sternotomy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Coronary Artery Bypass Graft, Median Sternotomy
- How many people
- 1,850 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Dec 2014
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.
Who may be able to join
- Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.
Who cannot join
- Those underwent coronary artery bypass graft surgery with mini-thoracotomy
- Those with insufficient study data recognized by electronic medical record
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Sangmin M. Lee, MD, PhD, 82-2-3410-0362, sangminm.lee@samsung.com
Won Ho Kim, MD, 82-2-3410-1994, bullet57@naver.com
About this study
The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.
Read the detailed description
Deep sternal wound infection after coronary artery bypass graft is a very dangerous complication as it prolongs hospital stay, increase morbidity and mortality, and increase cost of care.
As a risk factor of surgical site infection, risk index reported by NNIS (national nosocomial infection surveillance), Euroscore, or Society of thoracic surgeon risk score are currently used. However, as various performances are reported regarding these index or scoring systems, and many factors are needed for these index or scoring system, there is a need to develop a more simple risk factor with better performance. We focused on the differential blood cell count, as the neutrophil and lymphocyte count are related to the degree of surgical invasion, and inflammatory response. Previous studies reported that the neutrophilia or lymphopenia is related to postoperative infection. Therefore, we are trying to evaluate the performance of preoperative or postoperative the blood cell differential count as a risk factor for sternal wound infection after coronary artery bypass surgery.
- Conditions
- Coronary Artery Bypass Graft, Median Sternotomy
- Keywords
- sternal wound infection, coronary artery bypass graft, risk factor
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 |
|---|---|---|
| Coronary Artery Bypass Graft Group | Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative surgical wound infection
postoperative surgical wound infection within first week after the end of coronary artery bypass graft surgery, classified as a superfical or deep sternal wound infection
Measured: within first week after the end of coronary artery bypass graft surgery
Secondary outcomes (10)
preoperative total leukocyte count
preoperative total leukocyte count
Measured: 1 day before surgery
preoperative neutrophil count
preoperative neutrophil count
Measured: 1 day before surgery
preoperative lymphocyte count
preoperative lymphocyte count
Measured: 1 day before surgery
postoperative total leukocyte count
postoprative total leukocyte count
Measured: 2 hour after the end of surgery
postoperative neutrophil count
postoperative neutrophil count
Measured: 2 hour after the end of surgery
postoperative lymphocyte count
postoperative lymphocyte count
Measured: 2 hour after the end of surgery
preoperative NNIS risk index
preoperative NNIS risk index
Measured: 1 day before surgery
preoperative EuroScore
preoperative EuroScore
Measured: 1 day before surgery
Preoperative STS
Preoperative STS (Society of Thoracic Surgeons risk score)
Measured: 1 day before surgery
the incidence of surgical reopen with surgical wound infection
the incidence of surgical reopen with surgical wound infection
Measured: within 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 1,850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangmin M. Lee, Samsung Medical Center
- Investigators
- Sangmin M. Lee, MD, PhD, Principal investigator, Samsung Medical CenterWon Ho Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629030
- Sponsor's protocol ID
- 2012-05-067-001
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2012
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT01629030
- Acronym / sponsor ID
- 2012-05-067-001
- Conditions
- Coronary Artery Bypass Graft, Median Sternotomy
- Keywords
- sternal wound infection, coronary artery bypass graft, risk factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,850 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Jun 2012 (estimated)
- 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.
The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.
Detailed description
Deep sternal wound infection after coronary artery bypass graft is a very dangerous complication as it prolongs hospital stay, increase morbidity and mortality, and increase cost of care.
As a risk factor of surgical site infection, risk index reported by NNIS (national nosocomial infection surveillance), Euroscore, or Society of thoracic surgeon risk score are currently used. However, as various performances are reported regarding these index or scoring systems, and many factors are needed for these index or scoring system, there is a need to develop a more simple risk factor with better performance. We focused on the differential blood cell count, as the neutrophil and lymphocyte count are related to the degree of surgical invasion, and inflammatory response. Previous studies reported that the neutrophilia or lymphopenia is related to postoperative infection. Therefore, we are trying to evaluate the performance of preoperative or postoperative the blood cell differential count as a risk factor for sternal wound infection after coronary artery bypass surgery.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Bypass Graft Group | – | –Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.
Key inclusion criteria (1 listed)
- Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.
Key exclusion criteria (2 listed)
- Those underwent coronary artery bypass graft surgery with mini-thoracotomy
- Those with insufficient study data recognized by electronic medical record
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
postoperative surgical wound infection
Time frame: within first week after the end of coronary artery bypass graft surgery
postoperative surgical wound infection within first week after the end of coronary artery bypass graft surgery, classified as a superfical or deep sternal wound infection
10 secondary outcomes
preoperative total leukocyte count
Time frame: 1 day before surgery
preoperative neutrophil count
Time frame: 1 day before surgery
preoperative lymphocyte count
Time frame: 1 day before surgery
postoperative total leukocyte count
Time frame: 2 hour after the end of surgery
postoperative neutrophil count
Time frame: 2 hour after the end of surgery
postoperative lymphocyte count
Time frame: 2 hour after the end of surgery
preoperative NNIS risk index
Time frame: 1 day before surgery
preoperative EuroScore
Time frame: 1 day before surgery
Preoperative STS
Time frame: 1 day before surgery
the incidence of surgical reopen with surgical wound infection
Time frame: within 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
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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.
Sangmin M. Lee, MD, PhD principal investigator
Samsung Medical Center
Won Ho Kim, MD, PhD principal investigator
Samsung Medical Center
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 Coronary Artery Bypass Graft and Median Sternotomy, run by Samsung Medical Center at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Jul 2014. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sangmin M. Lee, MD, PhD (82-2-3410-0362, sangminm.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative surgical wound infection (time frame: within first week after the end of coronary artery bypass graft surgery). 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 9 Jul 2014.