Effectiveness of bundled intervention in surgical site infections among patients undergoing clean orthopedic surgery with hardware implants: A randomized controlled trial.

Summary

Title: Effectiveness of bundled intervention in surgical site infections among patients

undergoing clean orthopedic surgeries with hardware implants: A randomized controlled

trial

Introduction: Despite the well documented literature on SSIs as a source of significant

morbidity and mortality, decreased health related quality of life, prolonged hospital stay

and the associated financial implications there is lack of data regarding the prevention

strategies being followed to reduce SSIs among the patients undergoing orthopedic

surgery. Recently, bundled interventions (screening, decolonizing carriers and optimized

peri-operative antimicrobial prophylaxis) have gained more attention and their

implementation has greatly decreased the rates of SSIs. However there are no published

studies from India on this regard, which prompted us to conduct a study and to determine

the efficacy and feasibility of the implementation of these bundled interventions in

Indian setting.

Rationale: The rationale of the study was to determine the efficacy and feasibility of the

implementation of these bundled interventions in Indian setting.

Objectives

The objective of the study was to determine the prevalence of S. aureus nasal carriage

and whether the implementation of a standardized bundled intervention influenced the

outcomes in patients undergoing clean orthopaedic surgery with hardware implants.

Methodology: A prospective randomized trial was performed from October 2019 to

June 2022. Five hundred and eleven patients undergoing orthopaedic surgery with

hardware implants were screened and a standardized bundle of care for selected carriers

that consisted of daily body cleansing with 2% Chlorhexidine Gluconate wipes and

application of 2% Mupirocin nasal ointment twice a day during five days before surgery.

The 2% Chlorhexidine Gluconate wipes were prepared under high sterile zone of

Pharmaceutics Lab of Pharmacology Department.

Results: We observed S .aureus nasal colonization of 17.2%. In the follow–up period,

PJI rate was higher, albeit not significantly, in S.aureus non-carriers than among S.

aureus carriers - 2.3% (8/346) vs 1.7% (1/61); p=1.0. Also, there was no significant

difference in SSI rates in the two groups [1.7% (1/58) vs 0.86% (3/308) ].The overall

PJI/SSI rates in treated and untreated carriers showed no significant difference [3.3 %

(1/30) vs 3.2 % (1/31);p=1] In the non-carrier group, majority of the SSI/PJI were due to

gram negative pathogens. PFGE analysis of 13 S.aureus isolates (or selected number of

isolates) was performed. Eight clones (I-VIII) were identified. Of these, there were

single isolate of clone III, V, VI, VII and VIII. Clone III and IV were the most frequent

clone.

Translational potential: The incidence of SSI after surgery is not falling. The in-house

designed and prepared chlorhexidine wipes can be used as a bundle element in various

SSI prevention bundles. The contribution of CHG wipes in various SSI prevention

bundles used in different types of surgeries viz., gynaecological surgeries, hysterectomy

for both benign and malignant indication, lower extremity vascular bypass procedures,

can be evaluated to obtain a more nauced understanding of their contribution to infection

rates. This simple bundle element can easily be implemented in settings with limited

resources.