From literature: charles k.Anderson, md, et al."association between gelatin¿thrombin matrix use and abscesses in women undergoing pelvic surgery." the american college of obstetricians and gynecologists.Published by lippincott williams & wilkins: vol.124, no.3 (b)(4) 2014: 589-595.Objective: to assess the association between the use of gelatin¿thrombin matrix and the development of pelvic abscess during hysterectomy as well as factors associated with surgeons¿ use of this product.Methods: data for patients undergoing hysterectomy for obstetric¿gynecologic pathology were abstracted from databases at a (b)(6) hospital between 2009 and 2012.Open and minimally invasive hysterectomies were included and vaginal hysterectomies were excluded.Blood loss, surgery type, comorbidities, abscess formation, and use of gelatin¿thrombin matrix were examined.Abscess was defined as a walled-off fluid collection (documented with computed tomography scan) with fever (greater than 38°c) or leukocytosis (greater than 11,000/microliter).Standard statistical models were used.Results: of the 413 patients identified, 213 (51%) underwent surgery for malignancy.Gelatin¿thrombin matrix was used in 166 patients (40%).The overall rate of abscess was low (3%).In bivariate analyses, blood loss greater than 500 ml (odds ratio [or] 3.9, 95% confidence interval [ci] 1.1¿12.9, p5.021], ascites (or 6.5, 95% ci 1.6¿26.1, p5.023), drain placement (or 4.5, 95% ci 1.3¿15.1, p5.009), and gelatin¿thrombin matrix use (or 7.0, 95% ci 1.5¿32.9, p5.009) were significantly associated with abscess formation.Multivariate logistic regression revealed that only gelatin¿thrombin matrix use predicted the development of pelvic abscess.Conclusion: we found that gelatin¿thrombin matrix use was associated with an increased risk of pelvic abscess.Although these products are important in the setting of bleeding, these data suggest that the liberal use of sealants is not without risk.------------- patient 8 of 9: it was reported from a literature article that a patient experienced pelvic abscess including/along with nausea, abdominal pelvic pain in which floseal was used.Post op day: 18 procedure: lavh indication for surgery: menorrhagia wbc count: 11.9 treatment: iv antibiotics, surgical exploration and drain placement culture of abscess: mixed anaerobic flora ct findings: 5.3x5.1-cm rim-enhancing fluid collection with septations in the right pelvis with gas ------------- nine (9) patients experienced pelvic abscess including/along with : patient 1 of 9: purulent vaginal drainage ¿ (b)(4) patient 2 of 9: abdominal or pelvic pain ¿ (b)(4) patient 3 of 9: fever, abdominal, pelvic pain ¿ (b)(4)patient 4 of 9: fever, abdominal or pelvic pain, surgical abdomen - (b)(4)patient 5 of 9: fever, nausea, abdominal pain - (b)(4)patient 6 of 9: anorexia, rectal pressure - (b)(4) patient 7 of 9: abdominal or pelvic pain - (b)(4) patient 8 of 9: nausea, abdominal pelvic pain - (b)(4) (this complaint) patient 9 of 9: abdominal pain, discharge - (b)(4).
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Complaint no: (b)(4) baxter medical assessment: from the safety profile of floseal use over more than a decade and several publications in abdominal and gynecologic surgery it is well known that incorrect product application in absence of active blood flow (the publication mentions that the gelatin matrix has been often used to prevent bleeding, which is a non-indicated use according to the product labeling), application of copious volumes of the hemostat without irrigation of product excess (material not reacted with the blood clot) may predispose to inflammatory reactions.Inflammation in the presence of a clean contaminated surgical field (according to lake et al, 2013, 99% of the hysterectomies, open and laparoscopic, are considered clean contaminated) may predispose to infection.Giving the limitations of a retrospective case review, and without knowing the relevant product application details for the respective nine cases with confirmed pelvic abscesses, we cannot exclude that floseal and its potential incorrect indication for use, and/or incorrect application, may have caused or contributed to the reported abscess formation.Review of the product labeling shows that all the related risks and correct use recommendations and warnings are adequate and do not require revision.No further clinical investigation is required.------------ a follow-up report will be submitted upon completion of baxter's investigation.
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