NCT01629030

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,850

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 9, 2014

Status Verified

July 1, 2014

Enrollment Period

2.5 years

First QC Date

June 25, 2012

Last Update Submit

July 8, 2014

Conditions

Keywords

sternal wound infectioncoronary artery bypass graftrisk factor

Outcome Measures

Primary Outcomes (1)

  • 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

    within first week after the end of coronary artery bypass graft surgery

Secondary Outcomes (10)

  • preoperative total leukocyte count

    1 day before surgery

  • preoperative neutrophil count

    1 day before surgery

  • preoperative lymphocyte count

    1 day before surgery

  • postoperative total leukocyte count

    2 hour after the end of surgery

  • postoperative neutrophil count

    2 hour after the end of surgery

  • +5 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.

You may not qualify if:

  • Those underwent coronary artery bypass graft surgery with mini-thoracotomy
  • Those with insufficient study data recognized by electronic medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Study Officials

  • Sangmin M. Lee, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR
  • Won Ho Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangmin M. Lee, MD, PhD

CONTACT

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 25, 2012

First Posted

June 27, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 9, 2014

Record last verified: 2014-07

Locations