跳至主要内容
临床试验/NCT01756534
NCT01756534Unknown不适用

The Effectiveness of an Oxidized Cellulose Patch Hemostatic Agent in Thyroid Surgery: a Prospective Randomized Controlled Study

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
The primary endpoint of the study was the postoperative volume of wound drainage

研究概览

简要总结

This single-blind prospective randomized study was designed to assess the efficacy and safety of the use of Surgicel® compared to the use of conventional surgical procedures (ligatures and bipolar electrocautery alone) to achieve hemostasis in thyroid surgery

详细描述

patients who require a thyroidectomy will be enrolled after informed consent will begiven. Prior to thyroidectomy, patients will be randomized to two groups: 1) use of conventional surgical procedures to achieve hemostasis,i.e., ligatures and bipolar electrocauterization alone, and 2) use of oxidized cellulose patch (Surgicel©) in addition to classical methods (ligature; bipolar electrocautery). All anticoagulants will be discontinued 10 days prior to the operation, if this will not be possible the patient will be excluded. The investigators will perform the specified procedure in accordance with accepted clinical practice standards. At the end of the thyroidectomy, a meticulous hemostasis will be achieved. Before wound closure, the sealed affiliation envelopes will be opened and 1-2×2 cm oxidized cellulose patch will be placed over the thyroid bed depending on patient randomization. Next, a suction drain will be placed. The drains will be removed when the secretion volume/day will be less than 20 cc.

All operations will be performed under general anesthesia by three head and neck surgeons who had experience in thyroid surgery. Outcome measures will include duration of operation, hemodynamic variables on emergence (blood pressure and heart rate), volume of secretion in the drain, time to removal of wound drain, length of postoperative hospital stay, and incidence of postoperative complications, i.e. hemorrhage, transient hypoparathyroidism, wound infection, seroma, and recurrent laryngeal nerve palsy. Evaluation of the postoperative course and recording of data will be done by one surgeons blinded to the intervention (MA). Follow-up for this study will be ended one month after the surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • •All patients who required a thyroidectomy

排除标准

  • •Unwilling or unable to consent
  • •Age < 18 years
  • •known allergy to oxidized cellulose
  • •Inability to discontinue use of anticoagulants 10 days before surgery
  • •Coagulopathy that could not be corrected

研究组 & 干预措施

CONVENTIONAL HEMOSTASIS

No Intervention

patients for whom conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone) were used to achieve hemostasis

SURGICEL

Active Comparator

patients will receive an oxidized cellulose patch (Surgicel®) in addition to conventional surgical procedures (i. e., ligatures and bipolar electrocautery alone)

干预措施: SURGICEL (Device)

结局指标

主要结局

The primary endpoint of the study was the postoperative volume of wound drainage

时间窗: 1 WEEK

次要结局

  • The secondary endpoints were events of bleeding requiring wound exploration under anesthesia(48 HOURS)
  • duration of drain use(1 WEEK)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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