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临床试验/NCT01317095
NCT01317095已完成不适用

A Prospective Randomized Study of Two Types of Sternal Closure After Open Heart Surgery: Rigid Sternal Fixation vs. Sternal Wire Closure

Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Intubation Time

研究概览

简要总结

The investigators are conducting this research to compare two different methods of closure of the sternum after cardiac surgery to determine if one method is better than the other. Open heart surgery always requires a sternotomy, and at the end of surgery the sternum needs to be closed. The sternum can be closed with Stainless Steel Wires or Sternalock rigid sternal closure system with equivocal results; however, the outcomes of these two methods have never been investigated in a randomized study. Thus, the investigators are conducting this study to compare two different methods of closure if one method demonstrates any recovery benefit over the other, using randomizing the subjects 1:1 to either rigid fixation with Sternalock or stainless steel wire closure. Recover benefit will be measured by postoperative intubation time, length of intensive care unit stay, and overall postoperative length of stay

详细描述

  1. Subjects:

Inclusion criteria:

  1. scheduled (elective or urgent) coronary artery bypass graft with or without valvular surgery by our cardiothoracic surgery division.
  2. patient age ≥18 and <80 .
  3. patient undergoing elective surgery.
  4. patient undergoing urgent surgery (defined as surgery scheduled while the patient is in the hospital and performed during the same hospital admission with stable medical condition)
  5. patients who is willing to sign the informed consent to participate the study.

Pre- operative exclusion criteria:

  1. patient undergoing redo-sternotomy.
  2. patient undergoing emergent surgery (defined as life-threatening or unstable condition requiring surgery on the same day of the surgical consultation.)
  3. patients on dialysis
  4. patients undergoing ventricular assist device insertion, transplant surgery, or aortic surgery.
  5. patients with body mass index ≥ 40.
  6. patients with active endocarditis.
  7. patients with known metal allergy.
  8. patient who refuses consent.
  9. patient who is unable to follow the postoperative instructions.

Intraoperative exclusion criteria:

  1. osteoporosis or poor quality of sternum.
  2. unstable sternal fracture.
  3. sternum too thin (less than 4 mm) or too thick (greater than 14 mm) as determined by direct measurement.
  4. bilateral mammary artery harvest (causing poor blood supply to the sternum).
  5. patients in whom the chest needs to be left open due to medical reasons.
  6. Procedures:

Preoperative testing, medical evaluation, cardiac surgery and postoperative care will all be performed per standard of care. The patients will sign a separate consent for their open heart surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled (elective or urgent) coronary artery bypass graft with or without valvular surgery by our cardiothoracic surgery division.
  • patient age ≥18 and <80 .
  • patient undergoing elective surgery.
  • patient undergoing urgent surgery (defined as surgery scheduled while the patient is in the hospital and performed during the same hospital admission with stable medical condition)
  • patients who is willing to sign the informed consent to participate the study.

排除标准

  • Pre- operative exclusion criteria:
  • patient undergoing redo-sternotomy.
  • patient undergoing emergent surgery (defined as life-threatening or unstable condition requiring surgery on the same day of the surgical consultation.)
  • patients on dialysis
  • patients undergoing ventricular assist device insertion, transplant surgery, or aortic surgery.
  • patients with body mass index ≥
  • patients with active endocarditis.
  • patients with known metal allergy.
  • patient who refuses consent.
  • patient who is unable to follow the postoperative instructions.
  • Intraoperative exclusion criteria:
  • osteoporosis or poor quality of sternum.
  • unstable sternal fracture.
  • sternum too thin (less than 4 mm) or too thick (greater than 14 mm) as determined by direct measurement.
  • bilateral mammary artery harvest (causing poor blood supply to the sternum).
  • patients in whom the chest needs to be left open due to medical reasons.

研究组 & 干预措施

Wire closure is the intervention

Active Comparator

Patients will have their sternum closed using stainless steel wires.

干预措施: Sternalock Rigid Fixation (Device)

Rigid fixation

Active Comparator

Patients will have their sternum closed by rigid fixation using Starnalock plates.

干预措施: Sternalock Rigid Fixation (Device)

结局指标

主要结局

Intubation Time

时间窗: 48 hours after surgery

The primary objective of this study is to determine if rigid sternal fixation can shorten the postoperative intubation time after open heart surgery compared to the wire closure

次要结局

  • Pain Scores.(5 days after surgery)
  • Length of ICU Stay(ICU stay)
  • Postop Length of Hospital Stay.(Until hospital discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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