Randomized, Single Blinded Pilot Study of Stainless Steel Wire Cerclage Versus FiberTape® Cerclage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Progression of sternal healing
研究概览
简要总结
This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery. The clinical, patient-reported, and imaging outcomes will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage.
详细描述
The primary objective of this study is to evaluate the progression of sternal healing in subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire.
The secondary objectives are to evaluate the complication rate and postoperative pain of subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire.
CT scans are performed at three months postoperatively to assess sternal healing. Two radiologists will read all CT scans. Axial slices are analyzed at five locations along the sternum (manubrium, top of the aortic arch, aortopulmonary window, main pulmonary arteries, and aortic root) using a 6-point quantitative scale (0=no sign of healing, 1=minimal healing, 2=mild healing, 3=moderate healing, 4=partial synthesis, 5=complete synthesis).
All adverse events related to the sternal closure procedure or the devices used for closure will be collected.
Postoperative pain scores will be collected using a 10 cm visual analog scale (VAS) with a numeric rating of 0 to 10. Sternal pain will be rated at rest, coughing, and with movement. Postoperative analgesic use for sternal closure pain will be evaluated.The Veterans Rand (VR-12) health survey will be collected postoperatively (see schedule of events for details).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant is blinded to study treatment and radiographers that assess CT scans are also blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is age 18 or over.
- •The subject has a planned full median sternotomy.
- •The subject has the ability to read, understand and sign the written informed consent document and complete the online surveys.
排除标准
- •The subject is having a re-operative sternotomy.
- •The subject is having an emergency or salvage operation.
- •The subject has an unplanned sternotomy incision.
- •The subject had an incomplete sternotomy.
- •The subject has chronic pain syndromes or chronic narcotic administration.
- •The subject has a history of chest irradiation.
- •The subject is unwilling to comply with study follow-up visits and surveys.
- •The subject has a sternal infection or suspected sternal infection.
- •The subject has any known comorbidity that will influence the outcomes.
- •The subject is considered vulnerable (i.e. prisoner, child, pregnant, handicapped, or mentally disabled person).
研究组 & 干预措施
Stainless Steel Wire Cerclage
Sternotomy closure using Stainless Steel Wire Cerclage
干预措施: Stainless Steel Wire Cerclage (Device)
FiberTape Cerclage
Sternotomy closure using FiberTape
干预措施: Stainless Steel Wire Cerclage (Device)
结局指标
主要结局
Progression of sternal healing
时间窗: 3 months post-operative
A CT scan will be used to assess sternal healing. Axial slices will be analyzed at 5 locations along the sternum using a 6 point quantitative scale. (0-no healing, 1- minimal healing, 2-mild healing, 3-moderate healing, 4-partial synthesis, 5-complete synthesis).
次要结局
- Complication rate(Collected at Immediate post-operatively, again at 3 weeks, 6 weeks, 3 months, 6 months)
- Analgesic medication Log(Collected at immediate post-operatively during hospital stay, again at 3 weeks, 6 weeks, 3 months and 6 months.)
- Visual Analog Scale (VAS)(Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months)
- Veteran's Rand Health Survey(Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months)