Wound Stat

[Surgicalcric]

Guys, this is coming down the pipe as you can see... It bears passing along to everyone using this stuff....

FROM
CDRUSAMMA FT DETRICK MD//MCMR-MMO-SO//

***PRIORITY***MESSAGE NOT RELEASED

****************UNCLASSIFIED****************

SUBJ: T0B-1218-002
NEW SOLDIER HEMOSTATIC DRESSINS / WOUNDSTAT / MEDICAL INFORMATION


REFERENCE: ALARACT 239/2008, NEW SOLDIER HEMOSTATIC DRESSINGS

1. THIS FRAGO DIRECTS TEMPORARY CESSATION OF USE OF WOUNDSTAT™ (WS) BY 68W COMBAT MEDICS AND ALL OTHER PROVIDERS DUE TO NEWLY IDENTIFIED SAFETY CONCERNS ABOUT THIS PRODUCT, PENDING FURTHER EVALUATION.

2. WOUNDSTAT™ WILL BE TURNED IN TO THE MEDICAL SUPPLY SYSTEM IMMEDIATELY. UNIT SUPPLY PERSONNEL WILL TURN -IN WOUNDSTAT™ TO THEIR SUPPORTING MEDICAL SUPPLY SUPPORT ACTIVITY (SSA). THE ARMY MEDICAL SSA WILL REVIEW TRANSACTION REGISTERS AND COMPLETE 100% CONTACT WITH UNITS ISSUED WS TO ENSURE TURN-IN OF PRODUCT. ARCENT WILL SUBMIT THE TOTAL NUMBER OF WS ISSUED AND COLLECTED TO OTSG. THE ARMY MEDICAL SSA WILL HOLD WS UNTIL FURTHER NOTICE OR UNTIL DISPOSITION INSTRUCTIONS ARE RECEIVED FROM OTSG.

3. DATA FROM THE US ARMY INSTITUTE OF SURGICAL RESEARCH (USAISR) SHOW THAT WS IS ASSOCIATED WITH A HIGH INCIDENCE OF BLOOD VESSEL THROMBOSIS AND DAMAGE TO THE VESSEL WALL. COMBAT GAUZE AND PLAIN KERLIX WERE NOT ASSOCIATED WITH SIMILAR FINDINGS. USE OF COMBAT GAUZE IS SAFE, ACCORDING TO CURRENT STUDIES, AND DISTRIBUTION AND USE SHOULD CONTINUE.

4. MEDICAL PERSONNEL MUST LOCATE AND EXAMINE ALL CASUALTIES PREVIOUSLY TREATED WITH WS TO VERIFY ADEQUATE LIMB PERFUSION, IF WS WAS USED TO TREAT EXTREMITY WOUNDS.

5. EXPIRATION DATE CANNOT BE DETERMINED.

[Red Flag 1]

Big change!

I'd like to see data that generated this change!!

Could this be a function of a Protamine direct/indirect effect??

Thanks Surgicalcric!!!


RF 1

[swatsurgeon]

you ask, you get:

First report:

PATHOLOGY REPORT
United States Army Institute of Surgical Research
3400 Rawley E. Chambers Avenue, Fort Sam Houston, Texas 78234- 6315 Phone: (210) 916-3349 Fax: (210) 916- 2004 DSN: 429
ACCESSION NUMBER:
R08-599~633 INVESTIGATOR :
Dr. Kheirabadi
DEPARTMENT:
PROTOCOL NUMBER:
A09-004
PROSECTOR:
Estep ANIMAL NUMBER:
multiple SPECIES: pig
BREED: York Cross SEX:
male
AGE:
WEIGHT:
DATE OF DEATH:
SACRIFICE METHOD:

DATE OF BIOPSY:
N/A DATE OF NECROPSY:
DATE TISSUE RCVD:
DATE OF REPORT:
10 Dec 2008
CLINICAL HISTORY
Protocol comparing tissue effects of WoundStat, Combat Gauze and Kerlix (standard cotton gauze). Collected for this study were vein, artery and nerve from injury site along with the lungs and brain. Sections from cranial and caudal lobes from both sides were collected as well as any lung that appeared abnormal. Brain was collected intact and sliced coronally after 24 hours. Coronal sections from the forebrain, midbrain and cerebellum were examined.
The artery and vein were systematically assessed adventitia, intima, and endothelium; for the presence of cellular infiltrates, foreign material and thrombosis. The section of nerve was assessed in the adventitia, nerve and perineural vessels, for the presence of cellular infiltrate, foreign material or thrombi. Lungs were assessed in the airways, interstitium, and vessels; for the presence of infiltrate, foreign material and thrombi and were further rated for the number of sections that contained thrombi. The brain was assessed for pathology in the parenchyma, interstitium, and vessels; for the presence of thrombi or foreign material.
PATHOLOGIC SUMMARY
Summary of Tissue Effects:
Kerlix:
Vein: mild adventitial fibrin and neutrophils; normal intima (2 of 8 had multifocal intimal degeneration and necrosis); diffuse minimal endothelial blebbing (1 of 8 had moderate endothelial degeneration); mild to moderate multifocal neutrophil adhesion and transmigration; and all sections 8 animals had several pieces of linear polarizing foreign material (cotton fiber)
Artery: minimal to mild adventitial neutrophilic inflammation and edema; minimal to mild transmural neutrophils; diffuse minimal endothelial blebbing; minimal to mild multifocal neutrophil adhesion and transmigration; and all sections contained several pieces of linear polarizing foreign material
Nerve: mild to moderate multifocal hemorrhage and edema; normal nerve; mild neutrophil marginalization in vessels; mild to moderate interstitial neutrophil infiltrate; and most sections contained several pieces of linear polarizing foreign material
Lung: normal airways; mild edema; neutrophil marginalization; no foreign material; and 6 of 9 animals had multifocal microthrombi
Brain: All sections were normal with the exception of animal 957 (R08-598) that had a subdural fibrin thrombi in the section form the midbrain.
Combat Gauze:
Vein: mild adventitial fibrin and neutrophils; normal intima (1 of 8 had minimal transmural neutrophils); diffuse minimal endothelial blebbing; minimal to moderate multifocal neutrophil adhesion and transmigration; and all sections 8 animals had several pieces of linear polarizing foreign material (cotton fiber)
Artery: mild adventitial neutrophilic inflammation and edema; minimal to mild transmural neutrophils; diffuse minimal endothelial blebbing; mild multifocal neutrophil adhesion and transmigration; and all sections contained several pieces of linear polarizing foreign material
Nerve: mild to moderate multifocal hemorrhage and edema; normal nerve; mild neutrophil marginalization in vessels ( 2 of 8 were moderate); moderate interstitial neutrophil infiltrate; and most sections contained several pieces of linear polarizing foreign material
Lung: normal airways; mild edema; neutrophil marginalization; no foreign material; and 2 of 8 animals had multifocal microthrombi
Brain: All sections were normal
WoundStat:
Vein: diffuse adventitial foreign material, fibrin and neutrophils; mild to moderate transmural degeneration and necrosis; diffuse severe endothelial loss; minimal to mild multifocal neutrophil adhesion and transmigration; all sections 8 animals had abundant adventitial and luminal gray granular polarizing foreign material (Wound Stat); and 7 of 8 animals had luminal of significant surface thrombi
Artery: Diffuse adventitial foreign material, fibrin and hemorrhage; mild to moderate transmural degeneration and necrosis; mild to moderate endothelial degeneration, necrosis and loss; mild multifocal neutrophil adhesion and transmigration; all sections contained abundant adventitial and minimal luminal gray granular polarizing foreign material; and 6 of 8 animals had luminal or significant surface thrombi
Nerve: mild to moderate multifocal hemorrhage and edema; normal nerve; mild to moderate neutrophil marginalization in vessels; mild to moderate interstitial neutrophil infiltrate; and most sections abundant adventitial and luminal gray granular polarizing foreign material
Lung: normal airways; mild edema; neutrophil marginalization; 1 of 8 animals had multifocal gray granular foreign material associated with a fibrin thrombi; and 3 of 8 animals had multifocal microthrombi
Brain: All sections were normal

Comments: The histologic findings for Combat gauze and Kerlix are equivalent in almost every way. Animals from the Kerlix group had a high incidence of microthrombi in the lung (6 of 9) and one animal had a thrombus in a vessel of the brain. WoundStat caused significant endothelial and mural injury in all 8 animals and most animals had large intraluminal thrombi. Within most of the luminal thrombi (8 of 8 veins and 6 of 8 of the arteries) there was gray granular polarizing material that has been previously confirmed to be WoundStat. This same material was found to be present in the lung of one animal. A large piece of WoundStat was associated with an arterial thrombus and there were multiple other areas that contained WoundStat in the lung of this animal.

Conclusion: This model performs as designed and is able to detect local vascular injury and distant microthrombi. WoundStat causes severe endothelial injury and significant transmural injury and possibly renders the injured vessels useless for surgical repair. It is possible for WoundStat to enter the vascular system and cause thrombosis at distal sites.

James Scot Estep
LTC, VC, DACVP
(210) 916-3349


Second report: next post....

[swatsurgeon]

second one.....

WoundStat (WS) Safety Study Dec 12, 2008

Phase I (non survival) experiments summary report:
Background: WS has been demonstrated to be the most effective agent against arterial bleeding that otherwise are fatal with gauze treatment in swine. This mineral (smectite) agent is in granular form and approved by FDA as a hemostatic device for temporary treatment of external bleeding. When mixed with blood, it forms clay materials that adhere to soft tissues and seal bleeding vessels. In addition, the WS granules have potent procoagulant activity similar to celite, a known clotting agent. In our earlier efficacy study, in which WS was 100% successful, microscopic residues of this agent were found in the lumen of treated arteries even after extensive wound debridement. Some endothelial damage was also seen in the vessels. These observations raised the possibility of thrombosis occurrence in WS- treated vessels following vascular repair and blood reflow. The current study examined this potential side effect of WS in an experimental model in swine with both arterial and venous injuries. In addition to treated vessels, the distal organs (lung and brain) that emboli may reside were also examined. The findings with WS were compared with another hemostatic device, Combat Gauze (CG) and regular gauze (Kerlix) control.

Methods: Anesthetized pigs were instrumented for baseline blood sampling, fluid infusion and vital signs monitoring. An incision was made in the neck area and  5 cm segments of right carotid artery and external jugular vein were isolated, clamped, and injured ( 50% transection). Free bleeding was allowed for 30 seconds. The hemorrhage was then controlled by packing the wound with two packages of WS, CG or Kerlix and manual compression ( a sequence of 2, 3, 10, 15, 15, 15….. min) until hemostasis was secured. To compensate for initial bleeding and restore normal blood pressure, 500-600 ml Hextend fluid was administered IV (50 ml/min, stating at 1st compression) to each pig to raise the MAP to the target pressure of 65 mmHg.

Two hours after treatment, the hemostatic materials were removed, vessels reclamped and wounds were debrided according to standard clinical procedure using 1 L (for CG and Kerlix) or 2 L ( for WS) of saline for flushing the wound thoroughly with bulb syringes. Next, blood vessels were flushed with additional saline, removing any residues or clots in the lumens, and repaired by suturing using a monofilament nylon suture (7-0 Prolene). During anastomosis, 1 L lactated Ringer’s (LR) fluid was administered IV to produce a mild hemodilution and prevent clotting at the suture line or beyond clamped area. No heparin was given to any of the animals during the experiment. Blood flow was then restored in both vessels (first artery and then vein) and the neck wound was sutured in three layers. Two hrs after blood flow, blood samples were collected for laboratory tests and animals were CT scanned to image the neck vasculature area. Wounds were then reopened, flow (or lack of it) through the individual vessel was confirmed and vessels were recovered for histology. In addition, the entire lung and brain were harvested, carefully examined for abnormalities and samples were taken for microscopic examination. Histological examination was done by a board certified veterinarian pathologist who was initially blinded to the identity of the samples.

Results: There were no differences in baseline hemodynamic and hematological measurements among groups. Blood clotting activity was significantly increased (hypercoagulable state) 2 hrs after blood circulation through the repaired vessels in all groups with no differences among treatment. This change was measured by thrombelastography (TEG) but was not detected by standard coagulation tests (PT, aPTT, fibrinogen), suggesting possible platelet activation.

Final flow through the repaired vessels were assessed by CT angiography and confirmed by direct observation when the wounds were reopened. Based on these data, all the vessels treated with gauze and CG were patent without any measurable difference in flow rate between the two groups. In addition, no significant thrombus or blood clot was found in the lumen or on the suture line of these vessels. The repaired segments of these vessels remained partially constricted. In contrast, 7 out of 8 carotid arteries treated with WS developed occlusive thrombosis and had no blood flow when examined at 2hrs. Similarly, 6 out of 8 jugular veins treated with WS developed large occlusive red clots and had no flow. Blood flow, however, was confirmed though these vessels at the time of suture repair. A layer of red thrombus was also seen on the inner wall of one of the patent vein. When lungs were examined in this group, a blood clot (2-3 cm long and 2-3 mm thick) was found in the lower lobe of one lung and a few residues, similar to WS materials, were detected the lung of another animal treated with WS.

The histological changes of CG- and Kerlix-treated vessels were equivalent in almost every way with minimal diffuse endothelial blebbing and no significant intraluminal thrombus. Animals from the Kerlix group had a high incidence of microthrombi in their lung (6 of 9) and one animal had a thrombus in a vessel of the brain. WS caused significant endothelial and transmural injury in all vessels and most vessels had large intraluminal thrombi. Within most of the luminal thrombi (8 of 8 veins and 6 of 8 arteries), there was gray granular material visible under polarizing light that has been previously confirmed to be WS. This same material was also found to be present in the lung of one animal. A large piece of WS was associated with an arterial thrombus and there were multiple other areas that contained WS in the lung of this animal.

Conclusion: This surgical model performs as designed and is able to detect local vascular injury/thrombus and distant microthrombi caused by hemostatic treatment. While CG produces changes that are not different from regular gauze, WS causes severe endothelial injury and significant transmural damage that possibly renders the injured vessels useless for surgical repair. It is possible for WS to enter the vascular system and cause thrombosis at distal sites.

Recommendation: The use of WoundStat should be restricted only for life threatening arterial hemorrhage from compressible nontourniquetable sites that are refractory to Combat Gauze. Surgeons should strongly consider repairing all arterial injuries treated with WoundStat at the prehospital level by interposition grafts.





Personnally, I 'm sticking with quik-clot. I've used it 7 times in the body and over a dozen on the outside....it works.

ss

[kawika]

I like quick clot better myself. Don't use any of the old stuff, we had a bad incident where my buddy got his forearm burned pretty significantly by it. Its been over a year and a half and his motor function still isn't 100%. Whos to say whether it would be like that without the additional burn or not, but I just don't take that chance anymore. Quick clot sponges work pretty good.

[swatsurgeon]

I like quick clot better myself. Don't use any of the old stuff, we had a bad incident where my buddy got his forearm burned pretty significantly by it. Its been over a year and a half and his motor function still isn't 100%. Whos to say whether it would be like that without the additional burn or not, but I just don't take that chance anymore. Quick clot sponges work pretty good.

The new formulation no longer has the exothermix reaction....i.e., it is MUCH safer.

ss

[Red Flag 1]

SS,

Thanks!!

It looks as though WS is no better/perhaps worse than a tourniquet in the final result. Amputation well above the WS application site likely the best treatment. Perhaps the initial results of WS application were a result of local vascular reaction that reduced local blood loss. It is clear that there was marked arterial reaction to WS.

Not the treatment of choice in a mid-limb injury, IMHO. I expect that WS was an attempt to provide the field medic with a quick apply and move on to the problem of hemostasis. I have seen WS discussed in other forums. There seems to be quite a bit of local vascular reaction to WS, with significant vascular tissue destruction! WS is not an apply and move on answer to bleeding from any site in the field. I am wondering if WS has made it into the civillian practice? My time now is mostly covering friends once or twice a month. I have not seen WS noted in any of my infrequent patients, have seen quick clot.


RF 1

ps: Has anyone seen any FDA response to WS ????

rf1

[swatsurgeon]

ps: Has anyone seen any FDA response to WS ????

Good question....does the FDA regulate these products???
Inquiring minds want to know...time to dig up info.

ss

[Red Flag 1]

SS,

May take a bit of time, as you and I know.

RF 1

[AngelsSix]

Okay, I am still learning here, but are you talking about the powder/grainy stuff?? We stopped using that a year ago and have switched to the patch style, sort of like gauze, if you will. I was told a year ago that the grain type that you pour into a wound does more damage than good and was not to be used unless a dire emergency was present (no medevac).

Edited to add we are using the HemCon stuff now....

[Surgicalcric]

Okay, I am still learning here, but are you talking about the powder/grainy stuff?? We stopped using that a year ago and have switched to the patch style, sort of like gauze, if you will. I was told a year ago that the grain type that you pour into a wound does more damage than good and was not to be used unless a dire emergency was present (no medevac).

Edited to add we are using the HemCon stuff now....

You are referring to the original Quick Clot, which IMHO was better than nothing at the time. The new stuff, QC ACS, is much better than the previous.


SS: Thanks for looking that stuff up.

Crip

[swatsurgeon]

ps: Has anyone seen any FDA response to WS ????

Good question....does the FDA regulate these products???
Inquiring minds want to know...time to dig up info.

ss


found the answer.....the fda did approve quik-clot but I could not find where wound stat had submitted for an "OK"....I need to search more before I label them a 'tag along' (get approved based on a similiar product without clinical research)

ss

[medicerik]

found the answer.....the fda did approve quik-clot but I could not find where wound stat had submitted for an "OK"....I need to search more before I label them a 'tag along' (get approved based on a similiar product without clinical research)

ss

The 510(K) docuemnt for WoundStat can be found at:
http://www.fda.gov/cdrh/pdf7/K071936.pdf

It definitely looks like a "tag along" versus seperate approval for a new type of device.

Erik

[Dub]

RF1: I am wondering if WS has made it into the civillian practice?

The Professor who is the major researcher responsible for WS's development gives a talk on it in one of his biochemistry lectures for M1s, as of this year he said it has been used in the MCV ER and is being carried by an ambulance department in Virginia - cannot remember which ambulance department.

[LeapingGnome]

Gents,

I met the TramaCure/WoundStat folks at SOMA last year and have spoken at length with them over the past year. They were very helpful and sent me all of the literature, studies, videos, etc. to review. This morning I called John Duke, one of the sales directors, to get some more direct information about the study and the ALARACT. He has seen this thread and is obviously keeping up to date on the developments and said that anyone can feel free to contact him for more information, or with any questions about the issue. He is going to be working through the holidays and said feel free to contact him at any time:

John A. Duke

Director of Sales, N. USA

TraumaCure

PHONE: 240-497-0910 • FAX: 240-497-0911

jduke@traumacure.com

(615) 790-2872 O.

(615) 791-8919 F.

(615) 330-5740 C.

www.traumacure.com

[Team Sergeant]

Gents,

I met the TramaCure/WoundStat folks at SOMA last year and have spoken at length with them over the past year. They were very helpful and sent me all of the literature, studies, videos, etc. to review. This morning I called John Duke, one of the sales directors, to get some more direct information about the study and the ALARACT. He has seen this thread and is obviously keeping up to date on the developments and said that anyone can feel free to contact him for more information, or with any questions about the issue. He is going to be working through the holidays and said feel free to contact him at any time:

John A. Duke

Director of Sales, N. USA

TraumaCure

PHONE: 240-497-0910 • FAX: 240-497-0911

jduke@traumacure.com

(615) 790-2872 O.

(615) 791-8919 F.

(615) 330-5740 C.

www.traumacure.com


Looks like Mr Duke is on board and I've cleared him hot so he can post now if he likes.

Welcome aboard Mr Duke.

Team Sergeant

[29G31]

RF1: I am wondering if WS has made it into the civillian practice?

The Professor who is the major researcher responsible for WS's development gives a talk on it in one of his biochemistry lectures for M1s, as of this year he said it has been used in the MCV ER and is being carried by an ambulance department in Virginia - cannot remember which ambulance department.

If by civilian you mean EMS/FR we were using it on our Tacmed team. I just removed it after hearing the presentation given at SOMA. We never had an opportunity to test it on an actual patient. I am looking at replacing all of our stock with Combat Gauze. I like this option because it looks like regular dressing when in the wound.... could get away with using on regular trauma calls. When I was at SOMA the manufacturer of the OLAES dressing was even discussing making the first few yards of their packing in their bandage GC. This would be a great product.. everything all in one package.

The system I work in only allows hemostatics and tourniquets to be used by SWAT medics. This decision was made by the trauma surgeons board and the agency medical directors all follow suite. I can understand their issue with hemostatics that are granular based but products like QC ACS+ and CG are easy to remove from the wound. I also understand that we have relatively short transport times but the use of a military type tourniquet seems to make perfect sense.

We are at a distinct disadvantage on this side by not having the benefit of live tissue training/testing when it comes to hemostatics so we try to get information from sources like this forum and SOMA. We have several local department members that were corpsmen who have used some of these products and given us good feedback. I always appreciate any information I get from you guys in the field.

Steve

[swatsurgeon]

If by civilian you mean EMS/FR we were using it on our Tacmed team. I just removed it after hearing the presentation given at SOMA. We never had an opportunity to test it on an actual patient. I am looking at replacing all of our stock with Combat Gauze. I like this option because it looks like regular dressing when in the wound.... could get away with using on regular trauma calls. When I was at SOMA the manufacturer of the OLAES dressing was even discussing making the first few yards of their packing in their bandage GC. This would be a great product.. everything all in one package.

The system I work in only allows hemostatics and tourniquets to be used by SWAT medics. This decision was made by the trauma surgeons board and the agency medical directors all follow suite. I can understand their issue with hemostatics that are granular based but products like QC ACS+ and CG are easy to remove from the wound. I also understand that we have relatively short transport times but the use of a military type tourniquet seems to make perfect sense.

We are at a distinct disadvantage on this side by not having the benefit of live tissue training/testing when it comes to hemostatics so we try to get information from sources like this forum and SOMA. We have several local department members that were corpsmen who have used some of these products and given us good feedback. I always appreciate any information I get from you guys in the field.

Steve

Steve,
If your trauma docs are wondering about human use in and out of the operating room for the quik-clot...tell them to email me. I have used it 7 times in the body in the operating room and 12-15x in the resuscitation bay. Would be happy to educate them.
ss

[afo417]

The Quik Clot First Responder Sponges, which I understand are the same as the ACS ... Are still safe to use?

[Surgicalcric]

Its still safe to use.

[afo417]

Thank you for the info.

I am putting together a blow out kit for my TAC Vest. I rec'd my EMT - B a few months back.

Should I include any NPA's or OPA's? Are they really used that often? If so, which ones and what are the advantages of one over the other?

I am paying for everything out of pocket, kind of thought about a combitube or King LT, not really easy to carry on a vest and a little pricey.

I have a CPR mask, Quik Clot, sponges, old style field dressings, asherman dressings, petroleum guaze, elastic wraps, EMT Shears, 4x4's, some rolled guaze, a CAT, and some ABD pads. Mostly concerned about gunshot or stab wounds.

[Surgicalcric]

afo417:

The search button is your friend; use it. This topic has been covered extensively and as such no need in rehashing it.

Crip

[afo417]

Thanks will do

[rcm_18d]

I teach TCCC utilizing a very realistic technique and have used the WoundStat on patient models. From a TFR(Tactical First Responder) or RFR(Ranger First Responder) standpoint the WoundStat seemed to be very effective on major bleeds. I understand the treat of Emboli is a real concern. The only places I would, and teach to use the hemostatic agents (regardless of the agent) are the places that a tourniquet will not work (i.e. Groin, Pelvis, Armpit). Tourniquets are the only option that should be considered for the extremities. Just because you place a tourniquet on the extremity doesn't mean they will loose that extremity. If they arrive at a CSH or med facility within 4 hours they have a very good chance of keeping the limb. There have been cases in theater of 6+ hours with a tourniquet and no limb loss. As it stands, with SOCOM, right now the standard is Combat Gauze. The agent that I, personally, have had the most success with is Celox. When used correctly I have had 100% success. When talking Hemostatic agents the training is more important than the agent. The operator, whoever they are, has to be able to identify where the blood is leaking out of the vessel, gain control with direct pressure apply the agent directly to the vessel and follow it up with direct pressure never letting up and finish with a pressure dressing. That whole two to three minutes of direct pressure after application and letting up is impractical in the tactical world. Out of all the hemostatic agents, the only agent I have had issues with it's use in the past is QC. It does work but it does cause massive tissue death in the wound. The QC ACS+ tea bag is OK but it has its issues as well. I like the powder forms of the agents best. When we did the invasion we had HD (Hemostatic Dressings). They were made from human blood products. All the clotting factors were impregnated onto a 4x4, but they took 32 man hours to make and cost $1000 a piece. Anyone seen these since '03.

[swatsurgeon]

I teach TCCC utilizing live tissue and have used the WoundStat on patient models. From a TFR(Tactical First Responder) or RFR(Raqnger First Responder) standpoint the WoundStat seemed to be very effective on major bleeds. I understand the treat of Emboli is a real concern. The only places I would, and teach to use the hemostatic agents (regardless of the agent) are the places that a tourniquet will not work (i.e. Groin, Pelvis, Armpit). Tourniquets are the only option that should be considered for the extremities. Just because you place a tourniquet on the extremity doesn't mean they will loose that extremity. If they arrive at a CSH or med facility within 4 hours they have a very good chance of keeping the limb. There have been cases in theater of 6+ hours with a tourniquet and no limb loss. As it stands, with SOCOM, right now the standard is Combat Gauze. The agent that I, personally, have had the most success with is Celox. When used correctly I have had 100% success. When talking Hemostatic agents the training is more important than the agent. The operator, whoever they are, has to be able to identify where the blood is leaking out of the vessel, gain control with direct pressure apply the agent directly to the vessel and follow it up with direct pressure never letting up and finish with a pressure dressing. That whole two to three minutes of direct pressure after application and letting up is impractical in the tactical world. Out of all the hemostatic agents, the only agent I have had issues with it's use in the past is QC. It does work but it does cause massive tissue death in the wound. The QC ACS+ tea bag is OK but it has its issues as well. I like the powder forms of the agents best. When we did the invasion we had HD (Hemostatic Dressings). They were made from human blood products. All the clotting factors were impregnated onto a 4x4, but they took 32 man hours to make and cost $1000 a piece. Anyone seen these since '03.

RCM_18D
You have hit the nail on the head...it is the operator, not the product that makes the largest significant difference...that being said, not all operaqtors are created equal as you well know.....make something idiot proof and they make a better idiot.
Free powders have inherent risks to the provider...ever get one of them in your eyes?? Ever try the debride it out of tissue when it has been in there for 1-4 hours. The Wound stat product, like all others have a down side. I have used most of them (except wound stat) and found inside the human body the new formulation of quick clot in the bags as well as their combat gauze and gauze sponges do a superior job of providing hemostasis. Like I tell people, you have to be convinced not by marketing but by practical APPROPRIATE use under the correct circumstances...an agent that has the least associated bad consequences and provides the most benefit for the indicated use is the one you should be using.

ss

[rcm_18d]

I do have experience with the surgical side of QC. During Anaconda in '02 numerous soldiers were MEDEVACed to K2 with QC in their wounds. Some of the soldiers did not have major bleeding associated with the wound. The GSW Major and Minor debridement of the wounds was extensive. Some of those kids are probably still in physical or occupational therapy. The product was distributed to soldier as a magic fairy dust that wound stop any bleeding (Mark Wahlberg in “Shooter”). I am not saying QC doesn't work, I am simply stressing training. I don't like the tea bags ACS+ because I want something I can get into every wound without having to rip open to much.
There are very few places that one can really receive the proper training from individuals that understand the duress that the operator will be under during the application(KISS-Keep It Simple Stupid). I would go so far as to say without proper training on the actual uses of the specific product it will do more harm than good. Idiot proof and unbreakable are non-existent!!
Swatsurgeon
Have you used Celox?
Anyone heard anything from Biopure on their Hemopure (Synthetic Bovine Hemoglobin) product? Our Vets still use it at their clinics but South Africa is the only place I have heard where it was used on humans. If it works and the FDA has put it off this long somebody should pay. I have been hearing about it since 2000.

Ryan

[rcm_18d]

Sorry read more. I have not had the experience of QC in the eye. I have seen someone else and figured I could skip the experience. I have had Celox in the eye and not a big deal. If you are ever around the vendors they will eat it to prove a point. I always ask them over and over to see how muany times I can get them to eat it. It must not be good on the guts!!

[Razor]

I always ask them over and over to see how many times I can get them to eat it.

I think we'd get along rather well. :D

You mention Tactical First Responder and Ranger First Responder in your post. That's the first I've heard of RFR; can you teach me about the difference?

[rcm_18d]

Tactical first responder is what the Navy (Group 2 East and Group 1 West) calls the TCCC course. There is some difference in East and West curriculum. They also require some additional requirements in the course, like environmental injuries. During their 6 month train up for their floats or deployments they are required to get TFR qualified. RFR is obviously the US Army Ranger version and I think it was the first. This was started by some awesome individuals after Solomia. This is a course taught to every young hooah during or after RIP prior to their first deployment. I believe they get retrained on the course once a year if possible.

Cpt Butler(Navy) and Col Bellamy(Army) were the driving force behind the whole movement.

http://www.au.af.mil/au/awc/awcgate/medical/tacmed-butler.htm

[Razor]

Thanks! Are there specific procedures added to RFR that go beyond TFR, or CLS for that matter?

[rcm_18d]

All of these different courses will vary by command and the individuals teaching it for obvious reasons. Medics all have a few or a ton of pet peeves. Kinda like the opinion analogy. TC3 is TCCC is Combat Causality Care and is pretty standard across the services. There are still some commands and organizations that teach the ABC's as they have been taught since before anyone was getting shot.

RFR has a lot more duress inflicted upon the operators (i.e. Loud music, bangs, harassment for the instructors, moulage, and settings in which conducted) than a typical CLS course. Not so much due to the curriculum but to the enthusiasm of the cadre. Most of these guys will understand the importance of gross vs fine motor skills and how these conditions will illustrate the tachy psychy effects induced by stress. Like the CLS course RFR teaches IV Saline locks. I am not a big fan of IV access at this level. RFR uses the acronym “Circulation Airway Breathing Disability(Mental Status) Exposure / Environmental control” for the primary survey.
,
The cricothyroidotomy can be taught in all these courses, depending on the level of the operator receiving the instruction. When the course has the resources to run advanced topics along with the basic course of instruction, it is covered. This is still and should be an advanced skill. I am not saying non-medical personnel should not be taught this. I am just saying it needs to be selective. There are some 18d's that I would let do this procedure on my child, yet there are some I would shoot with the last bullet if they came to my aid. I am also a fan of the vertical incision. I don't care about the scar. I care about the ease of the procedure. This is an example of just one area all these courses can vary.

TFR typically does not include IV access but does include a painful and blah blah section on environmental injuries. The east coast uses “Situation/Self-aid Circulation Airway Breathing” for their primary survey. The west coast uses “Bleeding Airway Tension pneumothorax Shock” as their primary.

The common ground between these are the basic principles of TCCC. Basics are what saves lives and the military has realized this.

[Razor]

The west coast uses “Bleeding Airway Tension pneumothorax Shock” as their primary.

You know they did that so they could use the acronym BATPiSs. :D

[rcm_18d]

Sweet! Will have to use that one. Company of Navy dude's and I am the token Army guy. Up hill battle, but it is what it is. You give to much credit to the Seals though.:lifter They can't spell good enough to make up an acronym. Much less one that makes word(s)!:confused: I do, by the way, work with the Seal that was shot in the chest by Oscar in Bosnia. I am sure there are a few that remember the story. Bigs!! You just can't make this stuff up!!

[Pacer]

Swat Surgeon...

Doc

Thanks for the research data on the WoundSatat.

A few posts ago, you note you've got an "empiric" series of pateints in your OR.

What has been your personal experience with Chitosan (Celox)? Especially intruqued with the "Celox -A" prep that comes in a syringe type applicator for use (theoretically) in a puncture type wound with inaccessable vascular involvement. Kinda negates the reservation with a "tampon" completing the disruption of the vessel....IF it works while awaiting your magic hands/dissection, etc.

Again, what has been your experience.

(Dr) Pacer ()

[Pacer]

Does anyone have real world follow up on Celox A in deep muscle bed penetrating wounds? Specifically operative reports and post op or autopsy evidence?

Pacer

[swatsurgeon]

Swat Surgeon...

Doc

Thanks for the research data on the WoundSatat.

A few posts ago, you note you've got an "empiric" series of pateints in your OR.

What has been your personal experience with Chitosan (Celox)? Especially intruqued with the "Celox -A" prep that comes in a syringe type applicator for use (theoretically) in a puncture type wound with inaccessable vascular involvement. Kinda negates the reservation with a "tampon" completing the disruption of the vessel....IF it works while awaiting your magic hands/dissection, etc.

Again, what has been your experience.

(Dr) Pacer ()

I would Never put a free powder/granule product down where I could not see it...the risk of embolization of one of these "free" products that could lead to DIC is too much for me to ever attempt it or suggest it.
My use of celox has been limited to the hospital ED where I now work. They stocked it for use in the emergency department as a back-up hemostatic agent for injured patients. After introducing quik-clot (combat gauze and the "tea-bags") to all of the staff, celox was gone and quik-clot was ordered. Did it work, yea, it did, was it a mess, yes. My issue with it was a patient that had it under a huge myo-cutaneos flap had it "washed out" and not all of it was removed and to dig it out to debride it out was a PAIN IN THE BUTT. Natural history of this stuff stayng around???? does it 'de-activate'?
the rules of engagement are different for military vs civilian patients and based on intracorporial use of quik-clot, I'm a believer in the product as are a lot of military practicioners.
I have had people ask me if they could administer celox down a wound track via syringe....What you need is pre-hospital pressure/tourniquet application then a trauma surgeon. In the field, you need a medic that can identify the problem, and use whatever skills and brain power are necessary to get the hemorrhage arrested until casevac, etc to a surgeon......
my experience with 18D's is that they will understand the procedures necessary to make the wound more "cooperative", I have been told stories of them doing what I do: enlarge the wound, get the exposure necessary to better create a solution...let your imagination run with that one.
Celox is a product like other products: they have their followers and believers and most of that comes from stories, 1/2 truths and little personnal experience....I really try to believe none until I use it far beyond what is talked about/written about myself, then I become a fan on a product, I test it in the operative field as well as the pre-operative one....doesn't mean I'm any more qualified to tell anyone anything other than what I have seen with my own eyes and that I have NO financial/personal/ conflict of interest in ANY product I use...too many people out there that can not say the same thing who are some of the proponents of these products
ss

[armymom1228]

The Sunday lead story in the Baltimore Sun is about woundstat and a few other products.. interesting.

thanks bunches for this thread. I found it totally fascinating.

http://www.baltimoresun.com/news/nation/bal-te.militarymed29mar29,0,7110366.story

edited to add: I think the article is decent, if a little sensationalistic..but it is the media.

[rcm_18d]

USSOCOM standared is currently Combat Gauze, or a least last Dec '08 at SOMA! Has anyone used this or heard of it being used on a human patient?

[swatsurgeon]

yes, I used it this past friday night in a patient.....hit by a bus, cracked the pancreas in half, split a 'horseshoe' kidney in half, splenic injury, colon injury, renal artery and vein injuries....could not get to the renal vessels well during the damage control phase of my operation so asked the nurse to open my bag and open the combat gauze and put it on the operative field.....worked like a charm....gave me hemostasis where pressure/surgicel and flo-seal didn't work. Came back to the site after dealing with all of the other injuries, fixed the artery but had to ligate the vein. It was nicely controlled with the combat gauze! My first use of it inside. Have used the 'tea bags' inside the body before with excellent results as well.

ss

[rcm_18d]

Thanks for the report swatsurgeon. I have had the same results on the patient models. I really like the impregnated gauze concept.
I have also had great results from Celox as well.
When we did the invasion for OIF I all the 18 series medics in 10th Group were issued a dressing called the HD. We had to all sign waivers and every operator had a green tag on their dog tags representing the waiver. Have you ever heard of these? We were briefed that they were made from the clotting factors of human blood products impregnated onto a 4 X 4. They were real expensive, ($1000 ea.), were briefed to take 32 man hours, a piece, to make, and were produced by the Red Cross. I have not seen them since and I know of only one use on a patient.

[swatsurgeon]

Yes I know the dressing. Much too expensive and the Red Cross could not guarantee no transmission of viral particles since it was made from human serum. It was like having FFP and cryoprecipitate on a gauze pad. Other products achieve the same goal.

[Pete]

Here is the Stars & Stripes Story

http://www.stripes.com/article.asp?section=104&article=62221

[swatsurgeon]

it's amazing that there is still press about quik-clot burning patients when that formula is no longer manufactured (x 2 yrs) and the new formula doesn't get above 105 degrees.
Clay in the blood stream is a bad thing hence why all free granular formulas are frowned upon by civilian and military docs.

ss

[ReconDoc242]

it's amazing that there is still press about quik-clot burning patients when that formula is no longer manufactured (x 2 yrs) and the new formula doesn't get above 105 degrees.
Clay in the blood stream is a bad thing hence why all free granular formulas are frowned upon by civilian and military docs.

ss

I think a big reason for this is that a few units have not phased out the old quik-clot yet. I have personally ran into the older stuff in country a few times, only way to discern it is recognition of the old package....and obviously the date.

[Doc Dutch]

I think a big reason for this is that a few units have not phased out the old quik-clot yet. I have personally ran into the older stuff in country a few times, only way to discern it is recognition of the old package....and obviously the date.

All,

This is a great thread. I wish all in the US military dealing with the injured / bleeding could read this. The reason for my post is to bolster what ReconDoc 242 mentioned.

I am just back from a course in CONUS. There the combat medic held up the Quikclot dressing and showed the other health care professionals the first generation, olive drab, tear top package of Quik Clot. I just about cringed. The medic told about 90 of us that the military had these new hemostatic bandages for patients "bleeding to death". Well, this was bad information as we are now into the "3rd generation" of hemostatic bandages with a major decrease in exothermic reactions. The medic had even mentioned how severe the burning could be. I realized that the medic was incorrect as we no longer use that formulation and that those that would actually be treating in theater and might see these sorts of bandages would be significant number, but they would potentially come in contact with some form of these dressings applied as previously listed here in this thread. I also know that the military surgeons know better than to use the first generation QuikClot having just been through the EWSC (Emergency War Surgery Course).

If there is any "older stuff" laying around like the first generation QuikClot that can seriously injure the badly wounded even more, we need to pull it ourselves and destroy those products in theater or tell those medics to get rid of it. Quik Clot (first generation) is great from a historical perspective but that is it. I doubt anyone would use a muzzle loaded rifle in today's armed conflicts, and I would not use the first generation QuikClot. Medicine has pushed to newer heights with what we learned earlier in OIF and OEF. By the way, I have no financial ties to QuikClot or any of the others. I do believe in tourniquets though, in theater and in the civilian world, but again no financial ties here either.

At this course, I was asked finally if I had any comments (where do you start) and I did mention that newer products were available and that if you see this older product, do not get it in your eyes, mouth or sinuses. I told them to cover it with a moist bandage and pack it until you are in the OR, especially when there is rotator wash from any helicopter or other aircraft.

If there is anyone going into theater, please educate people on these fine points. People need to get caught up on these new products (problems and dangers, risks and benefits). I wish every medical personnel going over to Iraq or Afghanistan and beyond could join this site and read this thread.

Anyway, ReconDoc 242, you are completely correct.

My best to all,

Dutch