title: Real-world surgical outcomes of a gelatin-hemostatic matrix in women requiring a hysterectomy: a matched case-control study.
abstract: BACKGROUND
  The aim of this study was to compare adverse events and surgical outcomes of hysterectomy with or without use of a gelatin-hemostatic matrix (SURGIFLO(®) ).
  
  
  METHODS
  Prospective case-control study (Canadian Task Force classification II2) of total hysterectomy (Piver Type 1) provided by surgeons in Australia between November 2005 and May 2015. Data were collected via SurgicalPerformance, a web-based data project which aims to provide confidential feedback to surgeons about their surgical outcomes. Of 2440 records of women who received a hysterectomy, 1351 were eligible for these analyses; 107 received SURGIFLO(®) hemostatic matrix to prevent postoperative blood loss and 1244 did not.
  
  
  RESULTS
  Patients with or without SURGIFLO(®) differed in age, Charlson comorbidity index, and American Society of Anesthesiologists physical status classification system score (ASA), and also differed in clinical outcomes. After matching for patient's age and ASA at surgery, patients with and without SURGIFLO(®) had comparable baseline characteristics. Matched patients with and without SURGIFLO(®) had comparable clinical outcomes including risk of developing vault hematoma, return to the operating room, transfusion of red cells, surgical site infection (pelvis), readmission within 30 days and unplanned ICU admission.
  
  
  CONCLUSIONS
  In a sample matched by age and ASA, SURGIFLO(®) neither prevented nor caused additional adverse events in women undergoing hysterectomy. Surgeons used SURGIFLO(®) more commonly among women who were older, had more comorbidities and a higher ASA score. This indicates that it may be most useful in complicated surgery or cases.
authors.affiliation: School of Medicine, University of Notre Dame, Sydney, NSW, Australia.
authors.forename: Helena
authors.identifier: http://orcid.org/0000-0002-0217-6574
authors.initials: H
authors.lastname: Obermair
authors.affiliation: Institute for Health and Biomedical Innovation, School of Public Health, Queensland University of Technology, Brisbane, QLD, Australia.
authors.forename: Monika
authors.identifier: http://orcid.org/0000-0002-1728-8085
authors.initials: M
authors.lastname: Janda
authors.affiliation: School of Medicine, The University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.|SurgicalPerformance Pty Ltd, Greenslopes Private Hospital, Brisbane, QLD, Australia.
authors.forename: Andreas
authors.initials: A
authors.lastname: Obermair
mesh_terms: D000367:Age Factors; D001315:Australia / Q000453:epidemiology; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D016022:Case-Control Studies; D015897:Comorbidity; D005260:Female; D005780:Gelatin / Q000627:therapeutic use*; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D010359:Patient Readmission / Q000706:statistics & numerical data; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D011446:Prospective Studies; D013530:Surgical Wound Infection / Q000453:epidemiology
chemical_list: D006490:Hemostatics; D005780:Gelatin
keywords: Hysterectomy; SURGIFLO® gelatin-hemostatic matrix; adverse events; surgical outcomes