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]

Originally Posted by 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.

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]

Originally Posted by 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....

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]

Originally Posted by 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]

Originally Posted by swatsurgeon

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