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| ID | Type | Description | Link |
|---|---|---|---|
| TCVGH- | Other Grant/Funding Number | Taichung Veterans General Hospital |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study (4DryField) | Experimental | Use 4DryField before closure of wound |
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| Control group | Placebo Comparator | Use traditional method for bleeding control before closure of wound |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polysaccharide based hemostat (4DryField PH) | Device | The intervention group uses polysaccharide based hemostat (4DryField PH) before closure of surgical wound |
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| Measure | Description | Time Frame |
|---|---|---|
| Drainage amount | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Hospitalization duration | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taichung Veterans General Hospital | Taichung | Taiwan | 40705 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6467625 | Background | 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. | |
| 10218949 | Background | 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. |
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| Device | No use of polysaccharide based hemostat (4DryField PH) before closure of surgical wound |
|
| 34392782 | Background | 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. |
| 7836593 | Background | 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. |
| 10259579 | Background | Knight GF. Firing without shooting yourself in the foot. Mich Hosp. 1983 May;19(5):33-5. No abstract available. |
| 6986944 | Background | 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. |
| 34661715 | Background | 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. |
| 18503851 | Background | 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. |