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by Jason Wagner, MD 
 
While infrequently a critical event in the ED, epistaxis is often that little rock in the shoe of an otherwise smooth shift. And it can be as frustrating for the EP as it can be for the patient. FloSeal represents a new, effective yet expensive answer to this common problem.

Epistaxis comes in three versions:  the fountain, the trickle and the dam. The first and last are usually easy to treat. The fountain, or gusher, you just pack, hope it’s not too posterior, and then observe. The dam – in which the patient fixes their own problem but still wants you to do something – you basically leave alone. The resistant trickle, the bleed that keeps slowly oozing despite direct pressure and/or cautery, is the real problem child of epistaxis. It doesn’t quite seem worthy of a full packing, but you have to do something in order to satisfy yourself as well as your patient.  Full packings are uncomfortable, unattractive and can cause cardiac and infectious issues particularly in the elderly.  So what to do?  FloSeal to the rescue.

FloSeal Hemostatic Matrix is a proprietary combination of cross-linked gelatin granules and topical human thrombin produced by Baxter Pharmaceuticals.  Originally created and used for interoperative bleeding it is seeing increasing use for control of bleeding in epistaxis.  While not the best at controlling severe epistaxis, as there is no pressure or tamponade created by FloSeal it is perfect for everything short of the “pumper.”  While some of the traditional packing methods are impregnated with hemostatic agents the benefit of FloSeal over these is mainly patient comfort.  Another nice benefit is that FloSeal does not require platelet activation allowing it to fully function even in anticoagulated patients.

FloSeal comes as three separate components that require mixing.  The kit comes with a bottle of calcium chloride, a bottle of human thrombin, a syringe pre-filled with gelatin matrix, a syringe for the CaCl/thrombin mixture, a mixing syringe, and a cute little mortar.  Mixing the product involves multiple steps but is pretty straightforward.  First you draw up the CaCl with a syringe and inject the liquid into the bottle containing the thrombin.  You then swirl the bottle to mix the solution.  Once mixed the solution is drawn out and then transferred to the mortar.  The solution is then aspirated into the mixing syringe which mates up with the syringe containing the gelatin matrix.  Finally you push the solution into the matrix side and then push the total mixture from side to side for a total of at least 20 transfers.  Wait 30 seconds and FloSeal is ready to use anytime in the next 30 minutes.

Now that the chemistry fun is over its time to put the final product to use.  Attach one of the two sizes of applicator tips to the syringe.  Place the tip deep into the nare and begin injecting the matrix solution as you slowly pull the syringe out uniformly filling the patient’s nare with foam.  The FloSeal will expand about 20% more in size filling the nare fully.  At this point it has the appearance of the same canned foam you might use to fill cracks in your house.  After 5 minutes FloSeal will form a gelatinous foam.  You can then use saline to remove any excess FloSeal from the patient’s face.  What the patient is left with is a comfortable non-bleeding nose filled with barely visible foam as opposed to a large uncomfortable balloon or packing with a tube or string taped to the side of their face.  The FloSeal will begin to break down in 3-5 days on its own and be gone in 5-7 days.

Per product literature and supported studies, FloSeal will stop 97% of bleeding within two minutes. This advance in patient comfort and technology does not come without a price, however.  FloSeal is sold in packs of 6 at a cost of $2,940 dollars or nearly $500 per use. This cost can be recouped by billing it as a medication separate from the procedure itself.  In my ED many of our patients are uninsured so in order to control out-of-pocket cost to the patient I address the expense with them prior to use of FloSeal.  FloSeal is FDA approved for general use in control of bleeding with no specific approval for epistaxis but has been used safely in the ENT literature.

How We Rate
1.  Seriously flawed, even hazardous
2.  Downsides outweigh upsides
3.  We could take it or leave it
4.  Excellent, with room to improve
5.  What did I do without this?

Jason Wagner, MD, has no affiliation with FloSeal or any other products mentioned in the Tech Doc column. To suggest a product for review, email This email address is being protected from spambots. You need JavaScript enabled to view it.
 

Comments   

# The Tech DocJason Wagner 2009-02-04 14:24
Follow me on Twitter for tech updates and musings. Twitter.com/the techdoc
Reply
# Steven Moss 2009-02-06 01:43
What happens when they bleed through the matrix anyway?
How hard is it to remove, or re-apply?
How much pressure does the goo apply externally before it expands along its long axis?

What happens if it is inhaled?

Does it act like an agar, promoting bacterial growth?
Reply
# The Tech DocJason Wagner 2009-02-06 03:16
If they bleed through the matrix you can suction what is left and easily place a Rhino Rocket or similar device.

If you're talking about removal if it doesn't stop the bleed see above. If you're talking about removal later there is no need as it dissolves. If you feel that things almost works and you just need a bit more then you can easily insert and reapply.

It does not really apply much tamponade at all which is why it doesn't work on rapid bleeds.

I've never had a Pt have trouble with inhaling the matrix. As I see it its about the same risk as a clot.

As there is no FDA indication for epistaxis the current literature does not comment on infection. To be safe I'd use antibiotic prophylaxis just as you would for any other packing.

Follow me on Twitter @Twitter.com/th etechdoc
Reply
# Cost of FlosealShawn Corwin 2009-02-11 03:34
Doing a simple search on the internet shows Floseal's cost is $85. Where does the $500 cost come from? If Floseal was only $85.00, that would definitely make it more reasonable to use regularly.

Also, just wanted to add a comment regarding filling the nasal cavity. You can use a cotton swab (q-tip), then get it wet with water. You can then insert the wet q-tip into the nares (on the lateral aspect, so as to not disturb the Floseal and the nasal septum. This way there is a passage so the patient can breath through the nares still. You can apply multiple "coats" to the septum.

Any recommendation for posterior bleeds with Floseal? I assume balloons are still the only way to go.
Reply
# The Tech DocJason Wagner 2009-02-11 11:29
The cost I quote is based on their literature which quotes a price of cases of $2940 for a 6 pack. This is also what our inventory people quote. I'll look into it when I return to the US. And yes in my opinion balloons are the way to go for posterior bleeds. Thanks for the tip and info.
Reply
# Tricia Engel 2009-04-08 13:15
Actually the cost of a 5ml Floseal is approximately $180 or even a little less if you are on a particular contract.
Reply
# Cost of FlosealNorm Norton 2009-06-10 21:46
Average cost in the NY/NY area is $165 for 5 ml syringe and $265 for 10 ml syringe.
Reply

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