Dataset Information

Does Preoperative Decolonization Reduce Surgical Site Infections in Elective Orthopaedic Surgery? A Prospective Randomized Controlled Trial.

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.

SUBMITTER: Rohrer F

PROVIDER: S-EPMC7371089 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Many patients having discretionary orthopaedic surgery take opioids daily, either with a prescription or illicitly, however little is known regarding the prevalence and effect of high-risk opioid use (eg, abuse, dependence) in the perioperative orthopaedic setting.We sought (1) to determine the prevalence of opioid abuse and dependence in patients undergoing major elective orthopaedic surgery; (2) to characterize the relationship of opioid abuse and dependence with in-hospital postoperative mortality and adverse events, failure to rescue, prolonged length of stay, and nonroutine disposition; and (3) to identify factors associated with high-risk opioid use.We used coding data collected in discharge records from the Nationwide Inpatient Sample (2002-2011). We analyzed changes with time in the prevalence of opioid abuse and dependence on admission. Finally, we used multivariate regression modeling to measure the association of opioid abuse and dependence with in-hospital postoperative mortality, morbidity, and resource utilization, and to identify factors associated with high-risk opioid use.The prevalence of opioid abuse and dependence increased from 0.095% in 2002 to 0.24% in 2011, an increase of 152% (p < 0.001). Opioid abuse and dependence were associated with increased inpatient mortality (odds ratio [OR], 3.7; 95% CI, 2.7-5.1) and aggregate morbidity (OR, 2.3 l; 95% CI, 2.2-2.4), including induced mental disorder (OR, 5.9; 95% CI, 5.4-6.3), respiratory failure (OR, 3.1; 95% CI, 2.7-3.6), surgical site infection (OR, 2.5; 95% CI, 2.0-3.0), mechanical ventilation (OR, 2.3; 95% CI, 2.0-2.5), pneumonia (OR, 2.1; 95% CI, 1.8-2.3), myocardial infarction (OR, 1.9; 95% CI, 1.3-2.6), and postoperative ileus or other gastrointestinal events (OR, 1.4; 95% CI, 1.3-1.6) (p < 0.001 for all listed entities). Abuse and dependence also were associated with increased risk for prolonged hospital length of stay (OR, 2.5; 95% CI, 2.4-2.5), nonroutine discharge (OR, 2.2; 95% CI, 2.2-2.3), and failure to rescue (OR, 2.0; 95% CI, 1.4-2.8). High-risk opioid users were more likely to be younger, male, nonwhite, Medicaid-insured patients with mental health and substance use disorders, and to be undergoing spine surgery. Hospital-related characteristics included urban setting, geographic location in the Northeast or West, and serving as a teaching facility.Opioid abuse and dependence are increasing rapidly among orthopaedic surgical inpatients and are associated with considerable postoperative morbidity and mortality and resource utilization. We recommend that orthopaedic surgeons screen patients carefully for opioid misuse preoperatively, help patients who are using opioids inappropriately to discontinue them before scheduling elective surgery, decline to perform elective surgery in patients who misuse opioids, and closely monitor patients who are habituated to opioids at the time they undergo surgery.Level III, prognostic study.

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