Pre surgical decolonization and impact on surgical site infections , of patients undergoing cardiac surgery at AIIMS New Delhi

Completed

Conditions: Other heart disorders in diseasesclassified elsewhere,

Registration Number: CTRI/2023/05/053005

Lead Sponsor: AIIMS New Delhi

Brief Summary: Despite advancements in surgical methods and an understanding of the pathophysiology of SSIs, surgical site infections remain a severe challenge for surgical civilization. There are many studies have reported that SSIs rank third among 3 common nosocomial infections, next to urinary tract and respiratory tract infections. Recent studies have also reported that the SSI rate ranges from 19.4% to 36.5% worldwide, whereas it ranges from 3% to 12% in India.

Approximately 50% of SSIs after cardiothoracic surgery are reported to be caused by Staphylococcus aureus, whereas coagulase-negative staphylococci and gram-negative bacteria are less frequently implicated. SSI remains a widespread problem that contributes to increased morbidity and mortality rates, prolongs the duration of hospital stay, and consequently increases healthcare expenditure. Several factors such as obesity, malnutrition, diabetes mellitus, and smoking, contribute to an increase in the incidence and severity of SSI.

The prevention of surgical site infections is becoming increasingly important to reduce the burden on patients, caregivers, and the healthcare system. Nurses play an important role in the pre-operative and post-operative care of patients. From decolonization of the nasal cavity, and preparation of the client for surgery to post-operative care of surgical wounds, change of surgical dressing helps reduce the burden of surgical site infections, reduces the duration of hospital stay and promotes early hospital discharge and post operative recovery. It has been estimated that approximately half of all the SSIs are preventable by implementing evidence-based strategies.

Nasal mupirocin is the most widely used topical antibacterial agent for nasal decolonization. It inhibits the synthesis of bacterial proteins by reversibly binding to bacterial is leucyl-tRNA synthetase and has excellent activity against Gram-negative organisms. In one study, short-term nasal mupirocin was found to be effective for MRSA decolonization with a success rate of 90% at 1 week after treatment. Neomycin is an aminoglycoside antibiotic active against both Gram-positive and Gram-negative bacteria. There is limited research into the efficacy of neomycin ointment for nasal MSSA decolonization. Leigh et al. showed neomycin achieved nasal decolonization in 61% of cases compared to 95% with mupirocin at 8 days after treatment.

Therefore, the goal of pre-surgical decolonization is to reduce the bacterial load so that less bacteria can transfer to the surgical site, as the development of a surgical site infection (SSI) is an important avoidable consequence of interventional surgery and 4 deserves to be better understood. Thus, the techniques used by nurses in current clinical care need strong supporting evidence to establish whether they minimize SSI.

Nasal decolonization prophylaxis not only reduces the burden of surgical site infections but also helps to reduce the mortality and morbidity of the patients undergoing cardiothoracic surgeries by preventing the colonization and growth of bacteria, transmission to the surgical sites that adds to the quality of life of patients and promote early recovery. As the prevalence of antibiotic-resistant strains continues to escalate, finding effective and targeted interventions is imperative.

This study delves into the rationale behind nasal decolonization and assesses its role in reducing the incidence of SSIs specifically within the context of adult cardiac surgery. By comparing the outcomes between patients receiving mupirocin or neomycin intranasal ointments and those without such prophylaxis, this research seeks to provide valuable insights into the optimal strategies for preventing SSIs in a high-risk surgical population. Also, as per the review of the literature and to the best of my knowledge no study has been conducted in an Indian healthcare setting to assess the efficacy of preoperative nasal decolonization using 2% Mupirocin or 0.5% Neomycin, in reducing the incidence and severity of SSI among patients undergoing cardiac surgery. The exploration of nasal decolonization in cardiac surgery patients not only addresses the pressing need for infection control but also aligns with the broader global efforts to combat antibiotic resistance. Through a comprehensive analysis of the effectiveness of these antimicrobial agents, this study aims to inform clinical practices, especially nursing interventions, guiding healthcare professionals towards evidence-based interventions. This will enhance patient outcomes and contribute to the overall advancement of surgical care in the realm of adult cardiac surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

Inclusion Criteria

Patients in age groups greater than 18 years of age undergoing any kind of cardiac surgery.
Patients who are not taking antibiotics recently.
Patients who are not under treatment for any kind of infection.

Exclusion Criteria

Patients having an allergy to 2% Mupirocin and 0.5% Neomycin.
Pregnant and lactating females undergoing cardiac surgeries.
Patients undergoing emergency cardiac surgeries.
Patients who have undergone re- exploration.
Patients who are on ECMO or IABP.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction in the incidence and severity of surgical site infections after application of 2%mupirocin and 0.5% neomycin intranasal ointment to adult patients undergoing cardiac surgery	2nd ,8th 14th and 30th post operative day
2.To compare the efficacy of 2% Mupirocin vs 0.5%Neomycin intranasal ointment in reducing the incidence of surgical site infections among adult patients undergoing cardiac surgery at AIIMS ,New Delhi	2nd ,8th 14th and 30th post operative day

Secondary Outcome Measures

Name	Time	Method
1.To assess the incidence & severity of surgical site infections among adult patients undergoing cardiac surgery at AIIMS, New Delhi.	2.To find out the association between selected demographic variables & clinical profile data with surgical site infection

Trial Locations

Locations (1): AIIIMS DELHI
🇮🇳
South, DELHI, India
AIIIMS DELHI
🇮🇳South, DELHI, India
POOJA THAKUR
Principal investigator
7827556001
thakur.aiims@gmail.com