[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....