Christoph Schimmer1, Justus Gross2, Elena Ramm2, Björn-Carsten Morfeld1, Grischa Hoffmann2, Bernd Panholzer2, Jürgen Hedderich3, Rainer Leyh1, Jochen Cremer2, Rainer Petzina4. 1. Department of Cardiothoracic and Thoracic Vascular Surgery, University Hospital Würzburg, Würzburg, Germany. 2. Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany. 3. Institute of Medical Informatics and Statistics, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany. 4. Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany rainer.petzina@uksh.de.
Abstract
OBJECTIVES: 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.
RCT Entities:
OBJECTIVES: 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: Julia Bayer; Zuzana Vackova; Hana Svecova; Petr Stirand; Julius Spicak; Jan Martinek Journal: Surg Endosc Date: 2017-06-27 Impact factor: 4.584