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Efficacy of universal preoperative decolonization with Polyhexanide in primary joint arthroplasty on surgical site infections. A multicenter before-and after-study.

ABSTRACT: BACKGROUND:Surgical site infections (SSI) are rare but severe complications after total joint arthroplasty (TJA). Decolonization measures prior to elective orthopedic surgeries have shown to reduce the risk of SSI with Staphylococcus aureus (S. aureus). OBJECTIVE:To determine the efficacy of universal decolonization with Polyhexanide on SSI rates with a focus on Staphylococcus aureus in patients with TJA. METHODS:Patients scheduled for elective hip or knee TJA in 5 participating certified orthopedic centers were included between 2015 and 2018 into this before and after study. Data on patients, surgeries and infections were prospectively collected. CDC-criteria were used to define and categorize Infections within 90?days after surgery. From January 2017 on, patients received decolonization sets containing Polyhexanide. Patients performed a 5?day decolonization regimen starting 4?days prior to surgery which included wipes, nasal decontamination and oral solution. RESULTS:Thirteen thousand, three hundred fifteen patients received TJA. During intervention 4437 decolonization sets were distributed among 7175 patients. Overall SSI rates increased from 0.68 /100 surgeries to 0.91/ 100 surgeries after implementation of the intervention (IRR 1.32; 95% CI 0.90-1.96). Time series analysis identified an increasing trend of SSI prior to the intervention. After implementation overall SSI rates plateaued. Regression analysis revealed surgery during intervention period to be an independent risk factor for developing a SSI (OR 1.34; 95%CI 1.18-1.53). Initial SSI rates due to S. aureus were 0.24/100 surgeries and decreased to 0.14/100 surgeries (IRR 0.57; 95% CI 0.25-1.22) after introduction of decolonization. Regression analysis revealed surgery during intervention period to be an independent protective factor for developing a SSI with S. aureus (OR 0.57, 95% CI: 0.33-0.99). Overall deep S. aureus SSI decreased significantly from 0.22/100 surgeries to 0.00/100 surgeries in patients adherent to protocol (IRR 0.00, 95% CI 0.00-.85). CONCLUSION:Universal decolonization with Polyhexanide did not reduce overall surgical site infections, but was effective in reducing Staphylococcus aureus - surgical site infections following elective joint arthroplasty. Polyhexanide could extend the list of alternatives to already established decolonization strategies. TRIAL REGISTRATION:The trial was registered at the German Registry for clinical studies www.drks.de ( DRKS00011505 ).

SUBMITTER: Wandhoff B

PROVIDER: S-EPMC7708093 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Efficacy of universal preoperative decolonization with Polyhexanide in primary joint arthroplasty on surgical site infections. A multicenter before-and after-study.

Wandhoff Björn B Schröder Christin C Nöth Ulrich U Krause Robert R Schmidt Burkhard B David Stephan S Scheller Eike-Eric EE Jahn Friedrich F Behnke Michael M Gastmeier Petra P Kramer Tobias Siegfried TS

Antimicrobial resistance and infection control 20201130 1

<h4>Background</h4>Surgical site infections (SSI) are rare but severe complications after total joint arthroplasty (TJA). Decolonization measures prior to elective orthopedic surgeries have shown to reduce the risk of SSI with Staphylococcus aureus (S. aureus).<h4>Objective</h4>To determine the efficacy of universal decolonization with Polyhexanide on SSI rates with a focus on Staphylococcus aureus in patients with TJA.<h4>Methods</h4>Patients scheduled for elective hip or knee TJA in 5 particip ...[more]

PMID: 33256845

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Project description:BackgroundSurgical 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/purposesOur 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?MethodsIn 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.ResultsAmong 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).ConclusionsWe 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 evidenceLevel II, therapeutic study.

Project description:BackgroundSurgical site infection is a devastating postoperative complication, and the occurrence ranges from 1% to 2% after total knee arthroplasty (TKA). The efficacy of the preoperative use of chlorhexidine for reducing infection has been debated. This meta-analysis aimed to examine the efficacy of the use of chlorhexidine to prevent surgical site infections after TKA.MethodsIn February 2017, a systematic literature review was conducted using the following electronic databases: PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, and the Google database. Data from randomized controlled trials (RCTs) and retrospective comparative study (RCS) that compared the use of chlorhexidine versus control washes to prep patients for TKA were retrieved. The primary endpoint was to compare the total incidence of infection with and without the use of chlorhexidine. The secondary outcomes were the incidence of infection in low-risk category patients, moderate-risk category patients, and high-risk category patients. After testing for publication bias and heterogeneity between studies, data were aggregated for random-effects modeling when necessary.ResultsFour clinical trials that included 8787 patients (chlorhexidine group: n = 2615, control group: n = 6172) were ultimately included in the meta-analysis. Chlorhexidine was associated with a reduced total incidence of infection, corresponding to a reduction of 1.69% [risk ratio (RR) = 0.22; 95% confidence interval (95% CI) = 0.12-0.40; P = .000]. Similarly, chlorhexidine was associated with a reduction in the incidence of infection among patients in the moderate-risk category (RR, 0.18; 95% CI, 0.05-0.63; P = .007) and the high-risk category (RR, 0.13; 95% CI, 0.03-0.67; P = .014). There was no significant difference between the incidence of infection in low-risk category patients with chlorhexidine use compared with the use of control washes (RR, 0.60; 95% CI, 0.22-1.60; P = .330).ConclusionThe preoperative use of chlorhexidine could reduce the total incidence of infection and the incidence of infection in moderate-risk and high-risk category patients. The overall evidence and the number of included studies was limited; thus, a greater number of high-quality RCTs is still needed to further identify the effects of chlorhexidine on reducing the incidence of infection after TKA.

Project description:BackgroundThe months prior to elective surgery may present an opportunity for patients to initiate behavior changes that will simultaneously ready them for surgery and improve their overall health status. An upcoming elective total joint arthroplasty (TJA) may serve as motivation for patients with severe obesity (body mass index [BMI]> 40 kg/m2) to lose weight, as it may optimize clinical outcomes following TJA and help them become eligible for TJA since some surgeons use a BMI of 40 kg/m2 as a cut-off for offering surgery in an effort to optimize outcomes.MethodsThe purpose of this multicenter randomized, controlled trial is to assess the feasibility and efficacy of a 12-week remote dietitian (RD) supervised dietary and physical activity weight loss intervention and mobile app for 60 patients with severe obesity prior to undergoing TJA. Intervention participants will receive access to a smartphone app and connect with an RD who will contact these participants weekly or bi-weekly via video calls for up to nine video calls. Together, participants and RDs will set goals for lifestyle modifications, and RDs will check on progress towards achieving these goals using in-app tools such as food logs and text messages between video calls. All patients will be encouraged to lose at least 20 pounds with a goal BMI < 40 kg/m2 after 12 weeks. Individuals randomized to the control group will receive clinical standard of care, such as nutritionist and/or physical therapy referrals. Outcome and demographic data will be collected from blood serology, chart review, mobile app user data, pre- and postintervention surveys, and phone interviews. The primary outcome measure will be weight change from baseline. Secondary outcome measures will include percentage of patients eligible to undergo TJA, number of sessions completed with dietitians, self-reported global health status (PROMIS Global Health scale), self-reported joint-specific pain and function (Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS)), and serologies such as hemoglobin A1c, total lymphocyte count, albumin, and transferrin. Qualitative responses transcribed from phone interviews about the intervention will also be analyzed.DiscussionThis will be the first study to assess pre-operative weight loss in patients with severe obesity anticipating orthopaedic surgery using an RD and mobile app intervention aimed at helping patients become eligible for TJA.Trial registrationRegistered on 1 April 2020 at Clincialtrials.gov. Trial number is NCT04330391 .

Dataset Information

Efficacy of universal preoperative decolonization with Polyhexanide in primary joint arthroplasty on surgical site infections. A multicenter before-and after-study.

Publications

Efficacy of universal preoperative decolonization with Polyhexanide in primary joint arthroplasty on surgical site infections. A multicenter before-and after-study.

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