Georg Daeschlein1, Matthias Napp2, Ojan Assadian3, Jessica Bluhm4, Colin Krueger5, Sebastian von Podewils1, Denis Gümbel2, Peter Hinz2, Hermann Haase1, Pascal M Dohmen6, Torsten Koburger7, Axel Ekkernkamp2, Axel Kramer4. 1. Department of Dermatology, University Medicine, Ernst-Moritz-Arndt University Greifswald, Germany. 2. Department of Trauma and Orthopaedic Surgery, Clinic of Surgery, University Medicine, Ernst-Moritz-Arndt University Greifswald, Germany. 3. Department for Hospital Hygiene and Infection Control, Medical University of Vienna, Austria. Electronic address: ojan.assadian@meduniwien.ac.at. 4. Institute of Hygiene and Environmental Medicine, University Medicine, Ernst-Moritz-Arndt University Greifswald, Germany. 5. Department for General, Visceral and Vascular Surgery, Vivantes Humboldt-Klinikum, Berlin, Germany. 6. Heart Centre Leipzig GmbH, University Clinic Leipzig, Leipzig, Germany. 7. Hygiene Nord GmbH, Greifswald, Germany.
Abstract
OBJECTIVE: Intraoperative bacterial contamination is a risk factor for surgical site infections (SSIs). This prospective, randomized, blinded, controlled trial (Reg. No. BB08/12) investigated the effect of a cyanoacrylate-based skin sealant (InteguSeal) on intraoperative wound contamination during trauma surgery. METHODS: A total of 128 patients undergoing trauma surgery were assigned randomly to an intervention (n=62) or a control group (n=66). Surgical sites were investigated at three locations: maximum incision depth (base), wound margin prior to wound closure (margin), and the surgical sutures (suture). Colony-forming units (CFU) were counted after 48h of incubation. RESULTS: Overall, significantly lower CFU counts were obtained for samples from the intervention group at all three sample sites compared to the control group. The difference, however, was only significant for the suture site (p=0.040). CONCLUSIONS: Preoperative sealing reduced microbial contamination on sutures during surgery, while the overall wound contamination remained unchanged. Hence, prevention of the clinically more relevant deep SSIs may not be expected. However, this study was not designed to detect differences in the rate of SSI. The role of the reduction in suture contamination with regard to the prevention of SSI remains to be evaluated.
RCT Entities:
OBJECTIVE: Intraoperative bacterial contamination is a risk factor for surgical site infections (SSIs). This prospective, randomized, blinded, controlled trial (Reg. No. BB08/12) investigated the effect of a cyanoacrylate-based skin sealant (InteguSeal) on intraoperative wound contamination during trauma surgery. METHODS: A total of 128 patients undergoing trauma surgery were assigned randomly to an intervention (n=62) or a control group (n=66). Surgical sites were investigated at three locations: maximum incision depth (base), wound margin prior to wound closure (margin), and the surgical sutures (suture). Colony-forming units (CFU) were counted after 48h of incubation. RESULTS: Overall, significantly lower CFU counts were obtained for samples from the intervention group at all three sample sites compared to the control group. The difference, however, was only significant for the suture site (p=0.040). CONCLUSIONS: Preoperative sealing reduced microbial contamination on sutures during surgery, while the overall wound contamination remained unchanged. Hence, prevention of the clinically more relevant deep SSIs may not be expected. However, this study was not designed to detect differences in the rate of SSI. The role of the reduction in suture contamination with regard to the prevention of SSI remains to be evaluated.