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CTRI Number  CTRI/2023/05/053005 [Registered on: 22/05/2023] Trial Registered Prospectively
Last Modified On: 28/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Pre surgical decolonization and impact on surgical site infections , of patients undergoing cardiac surgery at AIIMS New Delhi  
Scientific Title of Study
Modification(s)  
A randomized controlled trial to evaluate the efficacy of 2% Mupirocin vs 0.5% Neomycin vs placebo intranasal ointment on prevention of surgical site infections among adult patients undergoing cardiac surgery in AIIMS, New Delhi 
Trial Acronym  RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR UJJWAL DAHIYA 
Designation  ASSOCIATE PROFESSOR  
Affiliation  AIIMS NEW DELHI  
Address  COLLEGE OF NURSING , AIIMS NEW DELHI
College of nursing AIIMS NEW DELHI
New Delhi
DELHI
110029
India 
Phone  9899770134  
Fax  26588663  
Email  ujjwaldahiya3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep R 
Designation  ASSISSTANT PROFESSOR  
Affiliation  AIIMS , NEW DELHI 
Address  DEPARTMENT OF CTVS ,AIIMS NEW DELHI
Aiims new delhi
New Delhi
DELHI
110029
India 
Phone  9968967087  
Fax  26588663  
Email  pradeep.r.reddy85@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ujjwal Dahiya  
Designation  Associate professor  
Affiliation  college of nursing AIIMS , NEW DELHI 
Address  College of nursing AIIMS NEW DELHI
Aiims new delhi
New Delhi
DELHI
110029
India 
Phone  7827556001  
Fax  26588663  
Email  ujjwaldahiya3@gmail.com  
 
Source of Monetary or Material Support  
AIIMS , NEW DELHIDEPARTMENT OF CTVS  
 
Primary Sponsor
Modification(s)  
Name  AIIMS New Delhi  
Address  Department of CTVS unit CNC Tower AIIMS NEW DELHI INDIA 110028 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
POOJA THAKUR  AIIIMS DELHI  DEPARTMENT OF CARDIOTHORACIC SURGERY , CT6 AND CT4 WARD
South
DELHI 
7827556001

thakur.aiims@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS New Delhi ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  0.5 % Neomycin intranasal ointment   Pea size amount of 0.5% Neomycin intranasal ointment will be applied twice at the time of admission and 2hours before the surgery on the anterior intranasal mucosa clockwise to the participants using a clean swab stick 
Intervention  2% Mupirocin intranasal ointment   Pea size amount of 2% Mupirocin intranasal ointment will be applied twice at the time of admission and 2 hours before the surgery on the anterior intranasal mucosa clockwise to the participants using a clean swab stick 
Comparator Agent  Placebo intranasal ointment  0.9% normal saline soaked once clean swab stick will be applied to the anterior intranasal mucosa clockwise twice at the time of admission and 2 hours before the surgery to the participants in control group  
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patients in age groups greater than 18 years of age undergoing any kind of cardiac surgery.
2. Patients who are not taking antibiotics recently.
3. Patients who are not under treatment for any kind of infection.


 
 
ExclusionCriteria 
Details  1. Patients having an allergy to 2% Mupirocin and 0.5% Neomycin.
2. Pregnant and lactating females undergoing cardiac surgeries.
3. Patients undergoing emergency cardiac surgeries.
4. Patients who have undergone re- exploration.
5. Patients who are on ECMO or IABP.
 
 
Method of Generating Random Sequence
Modification(s)  
Random Number Table 
Method of Concealment
Modification(s)  
An Open list of random numbers 
Blinding/Masking
Modification(s)  
Participant and Investigator Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
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
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
Modification(s)  
Outcome  TimePoints 
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  
2nd 8th 14th & 30th post operative day  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="180" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2023 
Date of Study Completion (India) 28/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Publication will be done in journals  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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.

 
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