- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01629030
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
-
Seoul, 대한민국, 135-710
- 모병
- Samsung Medical Center
-
부수사관:
- Sangmin M. Lee, MD, PhD
-
부수사관:
- Young Tak Lee, MD, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.
Exclusion Criteria:
- Those underwent coronary artery bypass graft surgery with mini-thoracotomy
- Those with insufficient study data recognized by electronic medical record
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
postoperative surgical wound infection
기간: 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
|
within first week after the end of coronary artery bypass graft surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
preoperative total leukocyte count
기간: 1 day before surgery
|
preoperative total leukocyte count
|
1 day before surgery
|
|
preoperative neutrophil count
기간: 1 day before surgery
|
preoperative neutrophil count
|
1 day before surgery
|
|
preoperative lymphocyte count
기간: 1 day before surgery
|
preoperative lymphocyte count
|
1 day before surgery
|
|
postoperative total leukocyte count
기간: 2 hour after the end of surgery
|
postoprative total leukocyte count
|
2 hour after the end of surgery
|
|
postoperative neutrophil count
기간: 2 hour after the end of surgery
|
postoperative neutrophil count
|
2 hour after the end of surgery
|
|
postoperative lymphocyte count
기간: 2 hour after the end of surgery
|
postoperative lymphocyte count
|
2 hour after the end of surgery
|
|
preoperative NNIS risk index
기간: 1 day before surgery
|
preoperative NNIS risk index
|
1 day before surgery
|
|
preoperative EuroScore
기간: 1 day before surgery
|
preoperative EuroScore
|
1 day before surgery
|
|
Preoperative STS
기간: 1 day before surgery
|
Preoperative STS (Society of Thoracic Surgeons risk score)
|
1 day before surgery
|
|
the incidence of surgical reopen with surgical wound infection
기간: within 1 month after surgery
|
the incidence of surgical reopen with surgical wound infection
|
within 1 month after surgery
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Won Ho Kim, MD, PhD, Samsung Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .