NCT07487636

Brief 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 4DryField.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 25, 2026

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

March 17, 2026

Last Update Submit

March 20, 2026

Conditions

Head and Neck

Outcome Measures

Primary Outcomes (1)

  • Drainage amount

    2 weeks

Secondary Outcomes (1)

  • Length of stay

    2 weeks

Study Arms (2)

Study (4DryField)

EXPERIMENTAL

Use 4DryField before closure of wound

Device: Polysaccharide based hemostat (4DryField PH)

Control group

PLACEBO COMPARATOR

Use traditional method for bleeding control before closure of wound

Interventions

Polysaccharide based hemostat (4DryField PH)DEVICE

The intervention group uses polysaccharide based hemostat (4DryField PH) before closure of surgical wound

Study (4DryField)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing head and neck operations

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

Location

Related Publications (8)

  • 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.

    PMID: 6467625BACKGROUND

  • Jayadev 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.

    PMID: 10218949BACKGROUND

  • Ziegler 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.

    PMID: 34392782BACKGROUND

  • Wiedmeier 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.

    PMID: 7836593BACKGROUND

  • Knight GF. Firing without shooting yourself in the foot. Mich Hosp. 1983 May;19(5):33-5. No abstract available.

    PMID: 10259579BACKGROUND

  • Hardy 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.

    PMID: 6986944BACKGROUND

  • Alsubaie 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.

    PMID: 34661715BACKGROUND

  • Chen 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.

    PMID: 18503851BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 25, 2026

Record last verified: 2025-11

Locations

TW(1)