title: An In Vivo Comparison of Hemostatic Gelatin Matrix Products in a Porcine Spleen Biopsy-punch Model.
abstract: 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.
authors.affiliation: Ethicon Inc., Somerville, New Jersey.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Hutchinson
authors.affiliation: Ethicon Inc., Somerville, New Jersey.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Werrlein
authors.affiliation: Ethicon Inc., Somerville, New Jersey.
authors.forename: Douglas B
authors.initials: DB
authors.lastname: Johns
authors.affiliation: Ethicon Inc., Somerville, New Jersey.
authors.forename: Gary
authors.initials: G
authors.lastname: Zhang
authors.affiliation: Ethicon Inc., Somerville, New Jersey.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Clymer
authors.affiliation: Ethicon Inc., Somerville, New Jersey.
authors.forename: Richard
authors.initials: R
authors.lastname: Kocharian
mesh_terms: D000818:Animals; D001706:Biopsy / Q000009:adverse effects; D001760:Bleeding Time; D016063:Blood Loss, Surgical / Q000517:prevention & control; D001794:Blood Pressure; D004195:Disease Models, Animal; D005260:Female; D005780:Gelatin / Q000627:therapeutic use*; D006487:Hemostasis / Q000187:drug effects*; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006490:Hemostatics / Q000627:therapeutic use*; D008297:Male; D013552:Swine
chemical_list: D006490:Hemostatics; D005780:Gelatin