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临床试验/NCT07487636
NCT07487636Enrolling By Invitation不适用

Polysaccharide Based Hemostat (4DryField PH) in the Shortening of Drainage Duration in Head and Neck Operations

Taichung Veterans General Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
Drainage amount

研究概览

简要总结

The aim of this study is to investigate whether 4DryField can reduce postoperative blood loss and drain duration following head and neck surgery.

This is a prospective, single-blinded, randomized study that will recruit 60 patients without coagulopathy, not on anticoagulant therapy, and with no known allergy to 4DryField.

详细描述

In head and neck surgery, surgeons often place surgical drains postoperatively to reduce the formation of hematomas or seromas. These drains are usually closed negative-pressure systems designed to remove excess blood or serous fluid and to help the skin flaps adhere properly. The duration of drain placement is closely related to the length of hospital stay. However, prolonged drain placement increases the risk of surgical site infection. Therefore, early removal of drains is particularly important in head and neck surgery.

4DryField (PlantTec Medical, Lüneburg, Germany) is an absorbable, polysaccharide-based powder that is applied directly to the surgical site. By absorbing water from the blood, it concentrates blood components and accelerates coagulation. Previous studies have confirmed the efficacy and safety of 4DryField. In a randomized clinical trial on hip arthroplasty, 4DryField was shown to reduce postoperative hematoma formation. Currently, there is still limited research investigating whether 4DryField can reduce postoperative bleeding and drain duration in head and neck surgery. Therefore, the aim of this study is to investigate whether 4DryField can reduce postoperative blood loss and drain duration following head and neck surgery.

This is a prospective, single-blinded, randomized study that will recruit 60 patients without coagulopathy, not on anticoagulant therapy, and with no known allergy to 4DryField. After a detailed medical history, physical examination, and explanation of the condition and treatment plan, patients who agree to participate and sign the informed consent form will be randomly assigned into two groups according to the type of surgery. Preoperative evaluations will include routine tests such as complete blood count, PT, APTT, chest X-ray, and electrocardiogram. In the experimental group, 1 g of 4DryField will be applied before wound closure after surgery, followed by placement of a negative-pressure drain and then wound closure. In the control group, the wound will be irrigated in the conventional manner before placing the negative-pressure drain and closing the wound. Postoperatively, daily drain output will be recorded. The two groups will be compared in terms of laboratory data, total drainage volume, and duration of drain placement. Statistical analysis will be performed to compare differences between the groups.

Keywords: Head & neck neoplasm surgery; hematoma;, drainage amount; 4DryFiel

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
None

入排标准

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

入选标准

  • Patients undergoing head and neck operations

排除标准

  • Allergy to 4DryField
  • Patients with coagulopathy
  • Patients underwent head and neck radiotherapy
  • Patients reluctant to join the study
  • Patients who had carotid blowout

结局指标

主要结局

Drainage amount

时间窗: 2 weeks

次要结局

  • Length of stay(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shih-An Liu

Professor

Taichung Veterans General Hospital

研究点 (1)

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