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
|
|
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
|
|
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. |