HemoStyp® Trauma Gauze TestingAll Studies complied with the current versions of the following regulations and guidances:
All Studies complied with the current versions of the following regulations and guidances:
Animal Welfare Act Regulations (9 CFR)
U.S. Public Health Service Office of Laboratory Animal Welfare (OLAW)
Guide for the Care and Use of Laboratory Animals(Institute of Laboratory Animal Resources, Commission on Life Sciences, National Research Council
HemoStyp Trauma Gauze™ Applied to Lateral Cut on Exposed Femoral Artery
The purpose of this study was to evaluate the hemostatic effect of Hemostyp and the response of the test animal systems to Hemostyp over time.
The necropsy results showed that no Hemostyp was visible at the vessel site or under the skin, and the surrounding tissue appeared normal. The histopathology results showed an absence of neutrophils and a relatively quiescent leukocyte response in the tissues where Hemostyp was placed, indicating that the gauze was not contaminated with bacteria and that the immune response to the gauze was of minimal severity. Overall, Hemostyp performed as postulated, providing a lattice/scaffold to assist in clot formation and then being completely broken down and removed by thebodies systems without apparent harm.
Comparison of HemoStyp Trauma Gauze to Lap Sponges in a Standard Swine Model of Uncontrolled Hemorrhage
The purpose of this study was to determine if Hemostyp Trauma Gauze is equivalent to the current standard of care (gauze pads) in achieving hemostasis.
Clinical pathology results showed the animals that received Hemostyp had slightly higher hematocrit (red blood cell level) counts and substantially higher mean Arterial Blood Pressure (MAP). Higher hematocrit counts would leave more red blood cells to deliver oxygen to organs and tissues of injured trauma patients before their red cell levels could be normalized through blood transfusion. Substantially higher MAP has even greater clinical significance for trauma patients, because MAP below 60 mm Hg is correlated with higher rates of vital organ dysfunction/failure, blood clotting abnormalities, and poor cardiovascular outcomes. Therefore, higher MAP from treatment with Hemostyp gauze would likely correlate with improved long‐term outcomes in trauma patients. Overall, this study confirmed that Hemostyp gauze is as efficacious, if not more, than surgical lap sponges..
Comparison of HemoStyp Hemostatic Gauze to Bloodstop Hemostatic Gauze for Body Surface and Liver Wounds
The purpose of this study was to accurately compare the hemostatic effect of Hemostyp gauze to that of Bloodstop gauze.
For both the body surface and liver wound models the average time to achieve hemostasis using Hemostyp hemostatic gauze and the average time to achieve hemostasis using Bloodstop hemostatic gauze were statistically the same, indicating that their hemostatic effects are identical. Additionally, Hemostyp gauze initiated clotting in every blood sample in the heparin anticoagulant tubes in just over 30 seconds on average. Overall, these results show that Hemostyp hemostatic gauze is equally as efficacious in achieving hemostasis as Bloodstop hemostatic gaze, and that Hemostyp gauze is capable of promoting blood clotting in patients with coagulation dysfunction.
MEM Elution GLP Report
The purpose of this test is to determine the cytotoxicity of extractable substances.
An extract of the test article was added to cell monolayers and incubated.The cell monolayers were examined and scored based on the degree of cellular destruction. The United States Pharmacopeia & National Formulary (USP <87>) states that the test article meets the requirements, or receives a passing score (Pass) if the reactivity grade is not greater than grade 2 or a mild reactivity. The cell monolayers were examined microscopically. The wells were scored as to the degree of discernable morphological cytotoxicity on a relative scale of 0 to 4. A grade of zero (0) indicates no cell lysis, intracytoplasmic granules. The test article passed all levels of dilution with a grade of zero (0).
ISO Intracutaneous Irritation Test
The purpose of this test was to determine if any chemicals that may leach or be extracted from the test article were capable of causing local irritation in the dermal tissues of rabbits.
None of the animals on study showed abnormal clinical signs during the 24, 48, and 72 hour observation periods. There were no significant dermal reactions observed at the injected test and control sites on the rabbits at the 24, 48, and 72 hour observation periods.
ISO Maximization Sensitization Test
This test was designed to evaluate the allergenic potential or sensitizing capacity of a test article.
The test was used as a procedure for the screening of contact allergens in guinea pigs and extrapolating the results to humans, but it does not establish the actual risk of sensitization. None of the animals in the study showed abnormal clinical signs during the test period. None of the negative control animals challenged with the control vehicles were observed with a sensitization response greater than zero (0). None of the test animals challenged with the test article extracts were observed with a sensitization response greater than zero (0). A negative sensitization incidence was interpreted for all test animals.
HemoStyp pH Test
The purpose of this analysis was to determine the pH of the test article in water.
The sample was submerged in laboratory grade water (total organic carbon (TOC) concentration <50ppb). One gauze strip was subjected to immersion in 10 mL of water for one hour. Two replicates were prepared. The pH of the water with partially dissolved gauze strip was measured with a Fisher brand Accumet AB15 pH meter. The HemoStyp sample was determined to have a pH of 7.21.
HemoStyp Dilution Test
The purpose of this analysis was to determine the changes to the material during submersion in water for set time points.
The sample was submerged in laboratory grade water (total organic carbon (TOC) concentration<50ppb). The material (two individual pieces per time point) was subjected to the water immersion for intervals of 1 minute, 10 minutes, 1 hour and 24 hours. Upon completion each sample was removed from the water and dried at 105oC prior to FTIR analysis.The data obtained during analysis of sample UHP Box of 2” x 2” Pouches indicates the material begins to dissolve in water within one minute. The sample is completely dissolved within 24 hours. Not enough material remains for analysis at the 24 hour time point.
Product Aging Study
The purpose of this study is to evaluate the effects of accelerated aging (shelf life) utilizing ASTM D3078-02 (Reapproved 2998)e1 standard test method for determination of leaks in flexible packaging by bubble emission.
The accelerated aging test for 1 year shelf-life, 2 years shelf life, and 3 years shelf life is conformed to the criteria.
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