Felix Rohrer1,2, Hubert Nötzli2,3, Lorenz Risch2,4, Thomas Bodmer4, Philippe Cottagnoud2, Tanja Hermann1, Andreas Limacher5, Niklaus Fankhauser5, Karoline Wagner6, Jan Brügger1,7. 1. F. Rohrer, P. Cottagnoud, T. Hermann, J. Brügger, Department of Internal Medicine, Sonnenhofspital, Bern, Switzerland. 2. F. Rohrer, H. Nötzli, L. Risch, P. Cottagnoud, University of Bern, Bern, Switzerland. 3. H. Nötzli, Orthopaedic Department, Sonnenhofspital, Bern, Switzerland. 4. L. Risch, T. Bodmer, Labormedizinisches Zentrum Dr Risch, Microbiology, Koeniz, Switzerland. 5. A. Limacher, N. Fankhauser, CTU Bern and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. 6. K. Wagner, Institute of Medical Microbiology, University of Zurich, Zurich, Switzerland. 7. J. Brügger, University of Zurich, Zurich, Switzerland.
Abstract
BACKGROUND: Surgical site infections (SSIs) after elective orthopaedic surgery are very stressful for patients due to frequent rehospitalizations with reoperations and poorer functional outcomes. Prevention of such events is therefore crucial. Although an evidence-based consensus is still lacking, preoperative decolonization could decrease SSI. Specifically, more information is needed about the effect of a preoperative decolonization procedure on SSI proportions in both Staphylococcus aureus carriers and non-S. aureus carriers after general orthopaedic surgery. QUESTIONS/PURPOSES: Our study addressed the following questions: (1) Does preoperative decolonization reduce the risk of SSI after general elective orthopaedic surgery in patients colonized with S. aureus? (2) Does preoperative decolonization reduce the risk of SSI among patients who are not colonized with S. aureus? METHODS: In this prospective, randomized, single-blinded trial, we recruited patients undergoing general elective orthopaedic surgery in one tertiary care center in Switzerland. Between November 2014 and September 2017, 1318 of 1897 screened patients were enrolled. Patients were allocated into either the S. aureus carrier group (35%, 465 of 1318 patients) or the noncarrier group (65%, 853 of 1318 patients) according to screening culture results. In the S. aureus group, 232 patients were allocated to the intervention arm and 233 were allocated to the control arm. Intervention was 5 days of daily chlorhexidine showers and mupirocin nasal ointment twice a day. Of the 853 noncarriers, 426 were allocated to the intervention arm and 427 were allocated to the control arm. All patients in both groups were analyzed in an intention-to-treat manner. The primary endpoint was SSI occurrence at 90 days postoperative and the secondary endpoint was SSI occurrence at 30 days postoperative.The initial sample size calculation was made for the S. aureus carrier group. Based on the literature review, a 4% proportion of SSI was expected in the control group. Thus, 726 carriers would have been needed to detect a relative risk reduction of 80% with a power of 80% at a two-sided α-error of 0.048 (adjusted for interim analysis). Assuming carrier prevalence of 27%, 2690 patients would have been needed in total. An interim analysis was performed after including half of the targeted S. aureus carriers (363 of 726). Based on the low infection rate in the control group (one of 179), a new sample size of 15,000 patients would have been needed. This was deemed not feasible and the trial was stopped prematurely. RESULTS: Among carriers, there was no difference in the risk of SSI between the intervention and control arms (decolonized SSI risk: 0.4% [one of 232], control SSI risk: 0.4% [one of 233], risk difference: 0.0% [95% CI -1.2% to 1.2%], stratified for randomization stratification factors; p > 0.999). For noncarriers, there was no difference in risk between the intervention and control arms (decolonized SSI risk: 0.2% [one of 426], control SSI risk: 0.2% [one of 247], stratified risk difference: -0.0% [95% CI -0.7 to 0.6]; p = 0.973). CONCLUSIONS: We found no difference in the risk of SSI between the decolonization and control groups, both in S. aureus carriers and noncarriers. Because of the low event numbers, no definite conclusion about efficacy of routine preoperative decolonization can be drawn. The results, however, may be helpful in future meta-analyses. LEVEL OF EVIDENCE: Level II, therapeutic study.
BACKGROUND: Surgical site infections (SSIs) after elective orthopaedic surgery are very stressful for patients due to frequent rehospitalizations with reoperations and poorer functional outcomes. Prevention of such events is therefore crucial. Although an evidence-based consensus is still lacking, preoperative decolonization could decrease SSI. Specifically, more information is needed about the effect of a preoperative decolonization procedure on SSI proportions in both Staphylococcus aureus carriers and non-S. aureus carriers after general orthopaedic surgery. QUESTIONS/PURPOSES: Our study addressed the following questions: (1) Does preoperative decolonization reduce the risk of SSI after general elective orthopaedic surgery in patients colonized with S. aureus? (2) Does preoperative decolonization reduce the risk of SSI among patients who are not colonized with S. aureus? METHODS: In this prospective, randomized, single-blinded trial, we recruited patients undergoing general elective orthopaedic surgery in one tertiary care center in Switzerland. Between November 2014 and September 2017, 1318 of 1897 screened patients were enrolled. Patients were allocated into either the S. aureus carrier group (35%, 465 of 1318 patients) or the noncarrier group (65%, 853 of 1318 patients) according to screening culture results. In the S. aureus group, 232 patients were allocated to the intervention arm and 233 were allocated to the control arm. Intervention was 5 days of daily chlorhexidine showers and mupirocin nasal ointment twice a day. Of the 853 noncarriers, 426 were allocated to the intervention arm and 427 were allocated to the control arm. All patients in both groups were analyzed in an intention-to-treat manner. The primary endpoint was SSI occurrence at 90 days postoperative and the secondary endpoint was SSI occurrence at 30 days postoperative.The initial sample size calculation was made for the S. aureus carrier group. Based on the literature review, a 4% proportion of SSI was expected in the control group. Thus, 726 carriers would have been needed to detect a relative risk reduction of 80% with a power of 80% at a two-sided α-error of 0.048 (adjusted for interim analysis). Assuming carrier prevalence of 27%, 2690 patients would have been needed in total. An interim analysis was performed after including half of the targeted S. aureus carriers (363 of 726). Based on the low infection rate in the control group (one of 179), a new sample size of 15,000 patients would have been needed. This was deemed not feasible and the trial was stopped prematurely. RESULTS: Among carriers, there was no difference in the risk of SSI between the intervention and control arms (decolonized SSI risk: 0.4% [one of 232], control SSI risk: 0.4% [one of 233], risk difference: 0.0% [95% CI -1.2% to 1.2%], stratified for randomization stratification factors; p > 0.999). For noncarriers, there was no difference in risk between the intervention and control arms (decolonized SSI risk: 0.2% [one of 426], control SSI risk: 0.2% [one of 247], stratified risk difference: -0.0% [95% CI -0.7 to 0.6]; p = 0.973). CONCLUSIONS: We found no difference in the risk of SSI between the decolonization and control groups, both in S. aureus carriers and noncarriers. Because of the low event numbers, no definite conclusion about efficacy of routine preoperative decolonization can be drawn. The results, however, may be helpful in future meta-analyses. LEVEL OF EVIDENCE: Level II, therapeutic study.
Authors: David H Kim; Maureen Spencer; Susan M Davidson; Ling Li; Jeremy D Shaw; Diane Gulczynski; David J Hunter; Juli F Martha; Gerald B Miley; Stephen J Parazin; Pamela Dejoie; John C Richmond Journal: J Bone Joint Surg Am Date: 2010-07-07 Impact factor: 5.284
Authors: Nalini Rao; Barbara A Cannella; Lawrence S Crossett; Adolph J Yates; Richard L McGough; Cindy W Hamilton Journal: J Arthroplasty Date: 2011-04-19 Impact factor: 4.757
Authors: Xan F Courville; Ivan M Tomek; Kathryn B Kirkland; Marian Birhle; Stephen R Kantor; Samuel R G Finlayson Journal: Infect Control Hosp Epidemiol Date: 2012-02 Impact factor: 3.254
Authors: Lonneke G M Bode; Jan A J W Kluytmans; Heiman F L Wertheim; Diana Bogaers; Christina M J E Vandenbroucke-Grauls; Robert Roosendaal; Annet Troelstra; Adrienne T A Box; Andreas Voss; Ingeborg van der Tweel; Alex van Belkum; Henri A Verbrugh; Margreet C Vos Journal: N Engl J Med Date: 2010-01-07 Impact factor: 91.245
Authors: Ricardo J G Sousa; Pedro M B Barreira; Pedro T S Leite; Ana Claudia M Santos; Maria Helena S S Ramos; António F Oliveira Journal: J Arthroplasty Date: 2015-08-14 Impact factor: 4.757
Authors: B C Young; A A Votintseva; D Foster; H Godwin; R R Miller; L W Anson; A S Walker; T E A Peto; D W Crook; K Knox Journal: J Hosp Infect Date: 2017-01-30 Impact factor: 3.926
Authors: Björn Wandhoff; Christin Schröder; Ulrich Nöth; Robert Krause; Burkhard Schmidt; Stephan David; Eike-Eric Scheller; Friedrich Jahn; Michael Behnke; Petra Gastmeier; Tobias Siegfried Kramer Journal: Antimicrob Resist Infect Control Date: 2020-11-30 Impact factor: 4.887
Authors: Felix Rohrer; David Haddenbruch; Hubert Noetzli; Brigitta Gahl; Andreas Limacher; Tanja Hermann; Jan Bruegger Journal: Perioper Med (Lond) Date: 2021-12-15
Authors: Felix Rohrer; Aresh Farokhnia; Hubert Nötzli; Frederik Haubitz; Tanja Hermann; Brigitta Gahl; Andreas Limacher; Jan Brügger Journal: Int J Environ Res Public Health Date: 2022-04-04 Impact factor: 3.390
Authors: Nusaiba F Baker; Owen Brown; Alexandra M Hart; Dora Danko; Christopher M Stewart; Peter W Thompson Journal: Plast Reconstr Surg Glob Open Date: 2022-03-22