4DryField PH and Head and Neck Operations.

March 20, 2026 updated by: Shih-An Liu, Taichung Veterans General Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Taichung, Taiwan, Taiwan, 40705
        • Taichung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing head and neck operations

Exclusion Criteria:

  1. Allergy to 4DryField
  2. Patients with coagulopathy
  3. Patients underwent head and neck radiotherapy
  4. Patients reluctant to join the study
  5. Patients who had carotid blowout

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study (4DryField)
Use 4DryField before closure of wound
Device: Polysaccharide based hemostat (4DryField PH)
The intervention group uses polysaccharide based hemostat (4DryField PH) before closure of surgical wound
Placebo Comparator: Control group
Use traditional method for bleeding control before closure of wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Drainage amount
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 2 weeks
Hospitalization duration
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CF25757A
  • TCVGH- (Other Grant/Funding Number: Taichung Veterans General Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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