Head and NeckNCT07487636
4DryField PH and Head and Neck Operations.
A study testing Polysaccharide based hemostat (4DryField PH) in people with Head and Neck, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck
- What is being tested?
- Polysaccharide based hemostat (4DryField PH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing head and neck operations
Who cannot join
- Allergy to 4DryField
- Patients with coagulopathy
- Patients underwent head and neck radiotherapy
- Patients reluctant to join the study
- Patients who had carotid blowout
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Conditions
- Head and Neck
- Being tested
- Polysaccharide based hemostat (4DryField PH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysaccharide based hemostat (4DryField PH)Device
The intervention group uses polysaccharide based hemostat (4DryField PH) before closure of surgical wound
Device
No use of polysaccharide based hemostat (4DryField PH) before closure of surgical wound
| Study group | Role | What they receive |
|---|---|---|
| Study (4DryField) | Experimental | Use 4DryField before closure of wound Receives: Device: Polysaccharide based hemostat (4DryField PH) |
| Control group | Placebo comparator | Use traditional method for bleeding control before closure of wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drainage amount
Measured: 2 weeks
Secondary outcomes (1)
Length of stay
Hospitalization duration
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-An Liu, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487636
- Sponsor's protocol ID
- CF25757A
- Other IDs
- TCVGH-
- Status last verified
- Nov 2025
- First submitted
- 17 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia de Alba GO, Garcia AR, Crespo FV. Pyretotherapy as treatment in West's syndrome. Clin Electroencephalogr. 1984 Jul;15(3):140-4. doi: 10.1177/155005948401500304.
PubMed 6467625Jayadev S, Smith RD, Jagadeesh G, Baukal AJ, Hunyady L, Catt KJ. N-linked glycosylation is required for optimal AT1a angiotensin receptor expression in COS-7 cells. Endocrinology. 1999 May;140(5):2010-7. doi: 10.1210/endo.140.5.6689.
PubMed 10218949Ziegler N, De Wilde RL. Reduction of adhesion formation after gynaecological adhesiolysis surgery with 4DryField PH - a retrospective, controlled study with second look laparoscopies. J Obstet Gynaecol. 2022 May;42(4):658-664. doi: 10.1080/01443615.2021.1928030. Epub 2021 Aug 14.
PubMed 34392782Wiedmeier RD, Arave CW, Arambel MJ, Kent BA, Walters JL. Effects of concentrated separator dried beet pulp on nutrient digestibility, milk production, and preference of Holstein cattle. J Dairy Sci. 1994 Oct;77(10):3051-7. doi: 10.3168/jds.S0022-0302(94)77247-7.
PubMed 7836593Knight GF. Firing without shooting yourself in the foot. Mich Hosp. 1983 May;19(5):33-5. No abstract available.
PubMed 10259579Hardy D. Breathing difficulties in the newborn. Br Med J. 1980 Jan 5;280(6206):48. doi: 10.1136/bmj.280.6206.48-a. No abstract available.
PubMed 6986944Alsubaie HM, Abu-Zaid A, Sayed SI, Pathak KA, Almayouf MA, Albarrak M, Aldhahri SF, Al-Qahtani KH. Tranexamic acid in head and neck procedures: a systematic review and meta-analysis of randomized controlled trials. Eur Arch Otorhinolaryngol. 2022 May;279(5):2231-2238. doi: 10.1007/s00405-021-07132-6. Epub 2021 Oct 18.
PubMed 34661715Chen CC, Wang CC, Wang CP, Lin TH, Lin WD, Liu SA. Prospective, randomized, controlled trial of tranexamic acid in patients who undergo head and neck procedures. Otolaryngol Head Neck Surg. 2008 Jun;138(6):762-7. doi: 10.1016/j.otohns.2008.02.022.
PubMed 18503851
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polysaccharide Based Hemostat (4DryField PH) in the Shortening of Drainage Duration in Head and Neck Operations
- ClinicalTrials.gov ID
- NCT07487636
- Acronym / sponsor ID
- CF25757A
- Conditions
- Head and Neck
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study (4DryField) | Experimental | Device: Polysaccharide based hemostat (4DryField PH)Use 4DryField before closure of wound |
| Control group | Placebo comparator | –Use traditional method for bleeding control before closure of wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing head and neck operations
Key exclusion criteria (5 listed)
- Allergy to 4DryField
- Patients with coagulopathy
- Patients underwent head and neck radiotherapy
- Patients reluctant to join the study
- Patients who had carotid blowout
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polysaccharide based hemostat (4DryField PH)The intervention group uses polysaccharide based hemostat (4DryField PH) before closure of surgical wound | Device | Study (4DryField) |
| No use of polysaccharide based hemostat (4DryField PH) before closure of surgical wound | Device | Control group |
Primary outcome
Drainage amount
Time frame: 2 weeks
1 secondary outcome
Length of stay
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Background: PubMed 6467625Garcia de Alba GO, Garcia AR, Crespo FV. Pyretotherapy as treatment in West's syndrome. Clin Electroencephalogr. 1984 Jul;15(3):140-4. doi: 10.1177/155005948401500304.
- Background: PubMed 10218949Jayadev S, Smith RD, Jagadeesh G, Baukal AJ, Hunyady L, Catt KJ. N-linked glycosylation is required for optimal AT1a angiotensin receptor expression in COS-7 cells. Endocrinology. 1999 May;140(5):2010-7. doi: 10.1210/endo.140.5.6689.
- Background: PubMed 34392782Ziegler N, De Wilde RL. Reduction of adhesion formation after gynaecological adhesiolysis surgery with 4DryField PH - a retrospective, controlled study with second look laparoscopies. J Obstet Gynaecol. 2022 May;42(4):658-664. doi: 10.1080/01443615.2021.1928030. Epub 2021 Aug 14.
- Background: PubMed 7836593Wiedmeier RD, Arave CW, Arambel MJ, Kent BA, Walters JL. Effects of concentrated separator dried beet pulp on nutrient digestibility, milk production, and preference of Holstein cattle. J Dairy Sci. 1994 Oct;77(10):3051-7. doi: 10.3168/jds.S0022-0302(94)77247-7.
- Background: PubMed 10259579Knight GF. Firing without shooting yourself in the foot. Mich Hosp. 1983 May;19(5):33-5. No abstract available.
- Background: PubMed 6986944Hardy D. Breathing difficulties in the newborn. Br Med J. 1980 Jan 5;280(6206):48. doi: 10.1136/bmj.280.6206.48-a. No abstract available.
- Background: PubMed 34661715Alsubaie HM, Abu-Zaid A, Sayed SI, Pathak KA, Almayouf MA, Albarrak M, Aldhahri SF, Al-Qahtani KH. Tranexamic acid in head and neck procedures: a systematic review and meta-analysis of randomized controlled trials. Eur Arch Otorhinolaryngol. 2022 May;279(5):2231-2238. doi: 10.1007/s00405-021-07132-6. Epub 2021 Oct 18.
- Background: PubMed 18503851Chen CC, Wang CC, Wang CP, Lin TH, Lin WD, Liu SA. Prospective, randomized, controlled trial of tranexamic acid in patients who undergo head and neck procedures. Otolaryngol Head Neck Surg. 2008 Jun;138(6):762-7. doi: 10.1016/j.otohns.2008.02.022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysaccharide based hemostat (4DryField PH) in people with Head and Neck, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drainage amount (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07487636, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.