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4DryField® PH - Haemostasis and Adhesions Prevention
PROVIDES HEMOSTASIS – PREVENTS ADHESIONS
ARTG No. 520347 Sponsor: KD & A Pty Ltd Distributed exclusively in Australia by IG Medical
About 4DryField PH
4DryField® PH is a sterile medical device indicated for adhesion prevention and haemostasis in surgical procedures. It consists of hydrophilic microporous particles manufactured from highly purified plant starch using SAFE™ technology.
4DryField® PH does not contain components of human or animal origin. It is biocompatible, pyrogen-free, and hypoallergenic.
Key properties: Non-cytotoxic. Binds many times its own mass of fluid within seconds. Absorbed within approximately 7 days.
Intended Use
4DryField® PH is intended for use by medical professionals in surgical procedures where:
- Prevention of postoperative adhesions is required in cavities with mesothelial or mesothelial-like lining
- Control of bleeding from arterioles, capillaries, or veins by conventional means is ineffective or impracticable
Suitable for open and laparoscopic procedures across general surgery, obstetrics, gynaecology, urology, orthopaedics, cardiac surgery, and other surgical specialties.
Clinical benefits
Adhesion Reduction (85%)1
Higher Pregnancy Rate2
Reduced Postoperative Pain2
Avoids Cauterization3
Reduced Hematoma Formation4
Reduced Lymphocele Formation5
1. Krämer et al. 2021 Langenbeck‘s Arch Surg 2. Krämer et al. 2023 J Clin Med 3. Moszynski et al. 2023 Medicina 4. Lucas et al. 2021 BMC Musculoskel Dis 5. Karsch et al. 2016 Adv Urol
4DryField® PH Product Variants
| Contents | SKU | Typical Applications |
|---|---|---|
| 5 x 1 g | SK0001-EU | Dental, ENT, minor surgical procedures |
| 3 x 3 g | SK0003-EU | General surgery, laparoscopic procedures |
| 3 x 5 g | SK0005-EU | Abdominal and pelvic surgery |
| 3 x 9 g | SK0009-EU | Major abdominal, cardiac, and orthopaedic surgery |
All variants are sterile and ready for immediate use.
4DFLap™ applicator
For laparoscopic procedures. Ergonomic handpiece. Flexible inner hose with memory effect. Suitable for current trocars from 5 mm
| Contents | SKU |
|---|---|
| 14 cm | LA0014-EU |
| 38 cm | LA0038-EU |
All variants are sterile and ready for immediate use.
Application
Haemostasis
Apply 4DryField® PH directly to the bleeding site. The powder absorbs fluid and forms a gel, assisting in the control of bleeding from arterioles, capillaries, and veins.
Adhesion Prevention
Apply 4DryField® PH powder to all areas requiring protection from adhesions. Soak with sterile solution until a blood-free gel forms. This creates a physical barrier between wound surfaces.
Two application options are available: in-situ gel formation or extracorporeally mixed gel. The quantity used depends on the intraoperative situation.
Safety Information
4DryField® PH meets the requirements for a Class III medical device.
Side effects have not been reported to date. Occasionally, a temporary CRP increase without leucocytosis and without temperature elevation may occur, which subsides without intervention after a few days (Ziegler et al., 2021).
Important: Read the instructions for use before use. Use only as directed by a qualified medical practitioner. Not all patients are suitable candidates for this device. The treating surgeon is responsible for evaluating each patient individually.
Frequently Asked Questions
Regulatory & Classification
Is 4DryField® PH approved in Australia?
Yes. 4DryField® PH is included on the ARTG and regulated by the TGA as a medical device.
What is the device classification?
It is classified as a Class III medical device under TGA regulations.
Is it PBS or MBS reimbursed?
No specific reimbursement listing exists. Use is subject to hospital procurement and private billing arrangements.
Mechanism of Action
How does 4DryField® PH achieve haemostasis?
The starch-based particles absorb fluid, concentrating clotting factors and forming a mechanical barrier to bleeding.
How does it prevent adhesions?
When mixed with saline, it forms a gel barrier that separates tissues during the critical healing phase.
Indications in Gynaecology
What procedures is it used for?
It is used in procedures such as myomectomy, endometriosis surgery, ovarian cystectomy, adhesiolysis, and hysterectomy.
Can it be used laparoscopically?
Yes. It is suitable for both open and minimally invasive procedures.
Application & Handling
How is it applied for haemostasis?
The powder is applied directly to the bleeding surface and gentle pressure may be used.
How is it prepared for adhesion prevention?
The powder is mixed with saline intraoperatively to form a gel and applied evenly to target surfaces.
Safety & Contraindications
Is it safe for intraperitoneal use?
Yes, when used according to Instructions for Use. It is resorbable and degraded over time.
Are there contraindications?
It should not be used in infected areas or intravascularly. Refer to IFU for full contraindications.
Evidence & Outcomes
Is there clinical evidence in gynaecology?
Clinical studies, including randomised trials, report reduction in adhesion formation when used as directed.
Practical Considerations
Does it interfere with imaging?
Residual material may be visible temporarily but is resorbed over time.
How long does it remain in the body?
It is typically resorbed within days.
Book a Demo
Technical Resources & Literature
Clinical References
1. Parker et al. 2007 Colorectal Dis, 2. Attard & MacLean 2007 Can J Surg, 3. Ellis et al. 1999 Lancet, 4. Parker et al. 2001 Dis Colon Rectum, 5. Weibel & Majno 1973 Am J Surg, 6. Operative Laparoscopy Study Group 1991 Fertil Steril, 7. Diamond et al. 1984 Infertility, 8. Bizer et al. 1981 Surgery, 9. Suter et al. 2000 Surg Endosc, 10. van Goor 2007 Colorectal Dis, 11. Parker et al. 2005 Colorect Dis, 12. Hirschelmann et al. 2012 Arch Gynecol Obstet, 13. Wilson et al. 2002 Colorect Dis, 14. Tingstedt et al. 2007 Br J Surg, 15. Sikirica et al. 2011 BMC Surg 16. Poehnert et al. 2015 J Biomater Appl, 17. Bioserv 2016 Study Report, 18. Hanke et al. 2011 ASA Meeting, 19. Karsch et al. 2016 Adv Urol, 20. Sieg et al. 2017 ARC J Anesthesiol, 21. Lucas et al. 2021 BMC Musculoskel Dis, 22. Korell 2014 Surgical Science, 23. Korell et al. 2016 Biomed Res Int, 24. Poehnert et al. 2015 Eur Surg Res, 25. Ziegler et al. 2016 J Med Case Rep, 26. Watrowski 2020 J Obstet Gynaecol, 27. Torres-de la Roche et al. 2020 Arch Gynecol Obstet, 28. Ziegler & De Wilde 2021 J Obstet Gynaecol, 29. Poehnert et al. 2016 Int J Med Sci, 30. Winny et al. 2016 Am J Transl Res, 31. Winny et al. 2016 Int J Med Sci, 32. Blumhardt et al. 2018 Case Rep Surg, 33. Ahmad & Crescenti 2019 Surg J, 34. Poehnert et al. 2019 Int J Med Sci, 35. Cesnjevar 2020 Study Report, 36. Krämer et al. 2021a Langenbecks Arch Surg, 37. Krämer et al. 2021b Facts Views Vis ObGyn
Ordering Information
IG Medical is the exclusive distributor of 4DryField® PH in Australia.
To place an order or request further information, email us at info@igmedical.com.au.
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