4DryField PH and Head and Neck Operations.

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство Polysaccharide based hemostat (4DryField PH)
  The intervention group uses polysaccharide based hemostat (4DryField PH) before closure of surgical wound
• Устройство
  No use of polysaccharide based hemostat (4DryField PH) before closure of surgical wound

Первичные конечные точки

• Drainage amount [Срок оценки: 2 weeks]

Вторичные конечные точки (1)

• Length of stay [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• Patients undergoing head and neck operations

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Taichung Veterans General Hospital — Taichung

Публикации

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Идентификаторы

NCT: NCT07487636 · CF25757A · TCVGH-

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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