title: Prevention of surgical site sternal infections in cardiac surgery: a two-centre prospective randomized controlled study.
abstract: OBJECTIVE
  Surgical site infection (SSI) of the sternum is a devastating complication in cardiac surgery. The aim of this prospective randomized controlled two-centre clinical study was to compare the use of a gentamicin-collagen sponge (Genta-Coll® resorb) and of a cyanoacrylate-based microbial skin sealant (InteguSeal®) on the SSI rate of the sternum.
  
  
  METHODS
  We analysed data from 996 consecutive patients following isolated coronary artery bypass grafting between 2012 and 2014. The patients were randomized into three groups: standard group (S-group), Genta-Coll group (G-group) and InteguSeal group (I-group). The primary study end-point was to analyse the incidence of superficial and deep sternal SSI. The secondary study end-point was to determine independent risk factors for an increased SSI rate.
  
  
  RESULTS
  Of the 996 patients investigated, 332 patients were in S-group, 336 patients in G-group and 328 patients in I-group. The mean age was 67.7 ± 9.4 years, 18.6% were women and the overall SSI rate was 6.2% with 2.2% deep sternal wound infections. SSI rates were 8.3% (S-group), 5.4% (G-group) and 4.9% (I-group) (P 0.16). Multiple regression analysis demonstrated a preoperative body mass index (BMI) of >30 kg/m2(P 0.047), re-thoracotomy for postoperative bleeding (P < 0.001) and sternum instability (P < 0.001) as independent predictors for an increased SSI rate.
  
  
  CONCLUSIONS
  The application of InteguSeal® or Genta-Coll® resorb had no significant influence on the incidence of the sternal SSI rate in 996 consecutive cardiac surgery patients but demonstrated a trend towards a benefit from using these prophylactic approaches. Multiple regression analysis demonstrated a preoperative BMI of >30 kg/m2, re-thoracotomy for bleeding and sternum instability as independent predictors for an increased sternal SSI rate.
authors.affiliation: Department of Cardiothoracic and Thoracic Vascular Surgery, University Hospital Würzburg, Würzburg, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Schimmer
authors.affiliation: Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Justus
authors.initials: J
authors.lastname: Gross
authors.affiliation: Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Elena
authors.initials: E
authors.lastname: Ramm
authors.affiliation: Department of Cardiothoracic and Thoracic Vascular Surgery, University Hospital Würzburg, Würzburg, Germany.
authors.forename: Björn-Carsten
authors.initials: BC
authors.lastname: Morfeld
authors.affiliation: Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Grischa
authors.initials: G
authors.lastname: Hoffmann
authors.affiliation: Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Panholzer
authors.affiliation: Institute of Medical Informatics and Statistics, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Hedderich
authors.affiliation: Department of Cardiothoracic and Thoracic Vascular Surgery, University Hospital Würzburg, Würzburg, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Leyh
authors.affiliation: Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
authors.forename: Jochen
authors.initials: J
authors.lastname: Cremer
authors.affiliation: Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany rainer.petzina@uksh.de.
authors.forename: Rainer
authors.initials: R
authors.lastname: Petzina
mesh_terms: D000287:Administration, Topical; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D019072:Antibiotic Prophylaxis / Q000379:methods*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D005839:Gentamicins / Q000008:administration & dosage*; D005858:Germany / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D056346:Sternotomy / Q000009:adverse effects*; D015503:Surgical Sponges; D013530:Surgical Wound Infection / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D000900:Anti-Bacterial Agents; D005839:Gentamicins
keywords: CABG; Cardiac surgery; Mediastinitis; Surgical site infection