PopSci, and The Hypodermic Full of Sponges: A Critical Look

xstat (1)XStat by RevMedX (via PopSci)

Recently, the internet “tactical” community has been a’twitter (and a’facebook and a’forum) with buzz about the RevMedX XStat hemostatic device and applicator. Specifically stemming from a Popular Science article about that product.

Essentially, the product is an applicator (looking very much like the child of a hypodermic syringe and an adult novelty) filled with 1cm discs of a sponge material, that’s been soaked in chitosan hemostatic. According to the PopSci article,

The sponges work fast: In just 15 seconds, they expand to fill the entire wound cavity, creating enough pressure to stop heavy bleeding. And because the sponges cling to moist surfaces, they aren’t pushed back out of the body by gushing blood. ‘By the time you even put a bandage over the wound, the bleeding has already stopped,’ [A RevMedX employee] says.”

The RevMedX website explains the product in the following way:

The XStat sponges are composed of standard medical sponge that is coated with a hemostatic agent and compressed. Each Xstat sponge contains a radiopaque marker for easy detection via X-ray.
In the wound, the Xstat sponges expand and create a barrier to blood flow, present a large surface area for clotting, and provide gentle pressure. No direct manual pressure is required.

Based on the PopSci article, and the follow on’s from The Blaze, I Fucking Love Science and others, the XStat is generating a great deal of buzz in social media and interest from potential end users. We wanted to step back, slow down, and take a harder look.
On one hand, this is great, as getting people interested in life saving tools is sometimes a challenge. On the other, the information being provided and the general perception of this as a new thing are troubling.

So, first thing first; Is it a bad idea?
In our opinion, no it is not a bad idea. It might however not be a necessary idea.
The concept of expanding material that is also coated with a hemostatic is interesting. The expanding product, as well as introducing hemostatic to assist the clotting process, would provide mechanical pressure in ways that could not be provided by conventional outside-to-in direct pressure.
That said, how is that superior to, or even that different from, gauze that is packed properly, providing pressure against the wound’s interior? Proper wound packing provides mechanical pressure not just from the exterior/top of a wound down, but inside the wound as well. A properly packed wound should be packed hard, the gauze or other material filling the cavity completely and being compressed until it is stiff. Once secured with a dressing, that mechanical pressure isn’t going anywhere and we would hazard is as good as, or better than, can be provided by expanding sponges.
It is also concerning that RevMedX states that the product provides “gentle pressure”. Hemorrhage control is not achieved with gentle pressure.

Next, despite the recent flurry of interest, the product is not exactly new, and it’s not available. We’ve been aware of it for around two years now, and it’s been brought up in various people’s work. When developing the Hemostatics: Myths, Lies, Facts and Applications lecture with Special Circumstances Inc. for the inaugural Paul-E-Palooza Conference, we encountered mention of XStat. Mention only, not independent study, and that mention was simply identifying it as a hemostatic technology in development. That status doesn’t appear to have changed: Right there on the website, RevMedX states “CAUTION: Investigational device. Limited by federal law to investigational use“. XStat remains in development, and not commercially available.

Thirdly, some of the things said in the PopSci article by RevMedX’s own John Steinbaugh, are basically bullshit.
Primary among these is this, “Gauze bandages just don’t work for anything serious[…]”
Gauze is the standard packing material against which other hemorrhage control is judged. Hemostatic studies? Judged against plain gauze. Whiz-bang mechanical interventions? Judged against plain gauze. Long before hemostatic agents were common place, lives were saved by packing with roller gauze. Today, and long into the future, lives will be saved by packing with roller gauze. Enough gauze, packed correctly (basically, until it’s hard and firm), will have an effect. With the gauze firmly packed, you have mechanical pressure against the bleeder(s). As it soaks with blood and that blood clots, you now also have a gauze that’s laden with the patients own clotting factors. It will work so long as a pressure dressing is properly used on top to secure that gauze, and it is not able to move and release pressure or break the clots formed.
Steinbaugh is also quoted saying “By the time you even put a bandage over the wound, the bleeding has already stopped,” as if that is somehow unique to XStat. In fact, this would be (or should be) the case with any other effective packing. By the time the dressing is going in place, the bleed is at least on the way to controlled. The dressing ensures that it stays that way.
That idea that XStat is somehow unique, and does things that other products don’t do, pervades the information and articles about the product. The PopSci article says that XStat will be “the first battlefield dressing created specifically for deep, narrow wounds”. That is simply untrue. Celox A, a syringe-like applicator filled with granulated Celox chitosan hemostatic, has been around for several years, specifically intended to apply hemostatic deep at the actual bleed. Celox Rapid Ribbon, a 1″ by 5′ long piece of chitosan impregnated gauze, is a new product from Celox designed to deal with deep and narrow wounds. Further, the “plain-old” hemostatic gauze products, QuikClot Combat Gauze, Celox gauze in it’s various forms, etc. all do what XStat is claimed to do when used properly. Those 4 yard or so rolls of gauze aren’t 12 feet long so they can only be used shallowly, and as noted above they serve to provide mechanical pressure, plus accelerated clotting, when properly packed.

Further, there is also the idea that X-Stat is somehow friendlier to the patient than other methods. With a standard diameter of 30mm’s, logic says that inserting the applicator into wounds is going to cause additional pain, just as wound packing does. The forthcoming smaller applicator is a step in the right direction, size wise, but inserting anything into a wound is going to remain painful. Pressure, no mater the source, adequate to control major hemorrhage will also remain painful.

The XStat has been vaporware for several years. If it comes to market finally, RevMedX is predicting a cost of $100. This is significantly more than QuickClot Combat Gauze, the Celox family of gauzes, or Celox-A applicators. From what is known and being reported now, XStat does not seem to us to offer anything superior to these extant, cheaper products. Products which have a long and successful track record, and also a long history of clinical testing.
Time will tell with XStat. It may indeed be the next big thing, but there is simply no way to say or know that now. All that we have now is a lot of hype and buzz, primarily from people who should be instead looking to the proven products that already solve the problems XStat is claiming exclusive domain over.

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