Safety Analysis of a Hemostatic Powder in a Porcine Model of Acute Severe Gastric Bleeding
Samuel A. GidayWilliam Van AlstineJohn Van VleetRichard DucharmeEric BrandnerMadalina FloreaKrystal JohnstonJosé Negrón-GarciaKimberly Ringenberger
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Keywords:
Hemostatic Agent
Hemostatics
Lumen (anatomy)
Sutures, hemoclips, and electrocautery are the primary mechanisms used to achieve hemostasis during gynecologic surgery, but in situations in which these are inadequate or not feasible, an array of hemostatic agents are available to help achieve hemostasis. These agents include physical agents such as cellulose, collagen, or gelatin products as well as biologic agents such as thrombin and fibrin products. Limited data are available on many of these agents, although their use is increasing, sometimes at high costs. In gynecologic surgery, hemostatic agents are likely most effective when used in areas of oozing or slow bleeding and as an adjunct to conventional surgical methods of hemostasis. Target Audience Obstetricians and gynecologists, family physicians Learning Objectives After completing this CME activity, physicians should be better able to identify various topical hemostatic agents and distinguish them from each other on the basis of mechanism of action, evaluate the potential complications associated with the use of topical hemostatic agents, and choose the optimal situations in which to use topical hemostatic agents in gynecologic surgery.
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Flowable gelatin matrix products have established themselves as effective, easy-to-use hemostatic agents useful in a variety of surgical situations. A recently reformulated gelatin matrix, Surgiflo® (Ethicon Inc., Somerville, NJ), can be prepared quickly and provides consistent flow over an 8-hr. period. No in vivo studies have yet been reported comparing hemostasis with the new Surgiflo to other currently marketed flowable gelatin matrix products. This study was conducted to determine whether Surgiflo in actual use has hemostatic qualities different from another commercial gelatin matrix. An in vivo model based on porcine spleen biopsy punch-induced bleeding was used to compare Surgiflo and Floseal™ (Baxter Healthcare Corporation, Hayward, CA), both with thrombin. Time required to achieve hemostasis and proportion of sites achieving hemostasis within 30 s were determined for both hemostatic agents and a control of saline-soaked gauze. Results were stratified by the degree of initial bleeding (mild, moderate, severe). Hemostasis was achieved within 3 minutes at all sites for both test products regardless of level of initial bleeding, and control sites continued bleeding past 10 minutes. There were no statistically significant differences between Surgiflo and Floseal for either mean time to hemostasis or proportion of sites hemostatic within 30 s. In this realistic in vivo model both gelatin matrix products were effective, and there were no significant differences observed in hemostatic efficacy between Surgiflo and Floseal. Other factors, such as ease of preparation and application, in-use stability, and economic considerations may affect a surgeon's decision in selection of a desirable hemostatic product.
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Bleeding time
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Objective To evaluate the hemostatic effects of topical hemostatic agents: gelatin sponge,absorbable hemostatic gauze,composite sponge and quick-acting styptic powder(FlashclotTM) on parenchymatous organ trauma in rabbits,and histological changes induced by these hemostatic agents.Methods A parenchymal organ active hemorrhage model was established by transecting the livers and spleens of rabbits about 1.0 cm away from anterior extremity under the condition of normal and liquemine anticoagulation respectively.Various hemostatic materials were dressed on the wound surface separately,and the bleeding time and blood lose were accurately recorded.Tissue samples were transected from the livers contacted with dressings for histology analysis.Results Under normal condition,the hemostatic time of gelatin sponge,composite sponge,absorbable hemostatic gauze,and FlashclotTM was(6.28±1.45)minutes,(6.19±1.04)minutes,(5.09±1.03) minutes and(4.07±0.84) minutes respectively,obviously shorter than that of common gauze(9.89±0.75)minutes(P0.05).Under the condition of liquemine anticoagulation,the hemostatic time of all groups increased obviously,especially the groups of gelatin sponge and absorbable hemostatic gauze.The result of histology analysis showed that FlashclotTM resulted in heat injury to the liver trauma area.Conclusion Both composite sponge and FlashclotTM present better hemostatic efficiency than gelatin sponge and absorbable hemostatic gauze,especially under the condition of liquemine anticoagulation.But FlashclotTM should only be applied to emergency hemostasis of life-threatening trauma due to the heat injury and difficulty in removing.
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Intraoperative hemostasis during neurosurgical procedures is one of the most important aspects of intracranial surgery. Hemostasis is mandatory to keep a clean operative field and to prevent blood loss and postoperative hemorrhage. In neurosurgical practice, biosurgical hemostatic agents have proved to be extremely useful to complete the more classic use of electrocoagulation. During recent years, many biosurgical topical hemostatic agents were created. Although routinely used during neurosurgical procedures, there is still a great deal of confusion concerning optimal use of these products, because of the wide range of products, as absorbable topical agents, antifibrinolytics agents, fibrin sealants and hemostatic matrix, which perform their hemostatic action in different ways. The choice of the hemostatic agent and the strategy for local hemostasis are correlated with the neurosurgical approach, the source of bleeding, and the neurosurgeon's practice. In this study, the authors review all the different sources of bleeding during intracranial surgical approaches and analyze how to best choose the right topical hemostatic agent to stop bleeding, from the beginning of the surgical approach to the end of the extradural hemostasis after dural closure, along all the steps of the neurosurgical procedure.
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Confusion
Intracranial bleeding
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Objective To study the hemostatic effects of topical hemostatic agents: gelatin fleece (GF),oxidized cellulose (OC) and gelfoam (GL) on hepatic trauma in rabbits,and histological changes induced by 3 topical hemostatic agents.Methods Three types of hemostatic agent were used in a uniform model of hepatic trauma of rabbit. The blood loss and time to hemostasis were accurately recorded. The materials were left in situ and animals were killed between 1 day and 8 weeks later to examine speed of absorption and histological changes of hemostatic agents.Results GF stopped bleeding more rapidly than GL or OC,and was absorbed almost completely at 8 weeks,with little histological changes.ConclusionGF is an absorbable material with better hemostatic effects and little histological changes.
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1. Allergic reactions can occur with the use of topical hemostatic agents. 2. Some hemostatic agents may be used in combination to provide more effective hemostasis (eg, thrombin and Gelfoam). 3. Documentation should be made of any hemostatic agent left in situ at the time of closure. 4. Use of topical hemostatic agents is generally contraindicated in contaminated wounds.
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