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CTRI Number  CTRI/2016/03/006767 [Registered on: 30/03/2016] Trial Registered Prospectively
Last Modified On: 10/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic
Preventive
Screening
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Bundled Intervention in reducing surgical site infections among patients undergoing clean orthopedic surgery with hardware implants. 
Scientific Title of Study   Effectiveness of bundled intervention in surgical site infections among patients undergoing clean orthopedic surgery with hardware implants: A randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Benu Dhawan 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 2075, 2nd floor,Teaching block, Department of Microbiology, AIIMS, Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  011-2654-6444  
Fax    
Email  dhawanb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Benu Dhawan 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 2075, 2nd floor,Teaching block, Department of Microbiology, AIIMS, Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  011-2654-6444  
Fax    
Email  dhawanb@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Benu Dhawan 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no 2075, 2nd floor,Teaching block, Department of Microbiology, AIIMS, Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  011-2654-6444  
Fax    
Email  dhawanb@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Hospital, Ansari Nagar East, New Delhi, Delhi 110029 
 
Primary Sponsor  
Name  AIIMS hospital 
Address  Ansari Nagar East, New Delhi, Delhi 110029  
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 
Dr Benu Dhawan  AIIMS, New Delhi  Department of Microbiology, Room No 2075, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi
New Delhi
DELHI 		 9311106715

dhawanb@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics committee,All India Institute of Medical Sciences,New Delhi  Approved 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, Patients posted for clean orthopedic surgery with hardware implants.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bundled Intervention  a. Screening: Using a sterile cotton swab, the anterior nares of the eligible patients will be swabbed during scheduled pre-operative clinic visits (usually 10-14 days, but no more than 30 days before the operations). Standard laboratory tests (standard bacterial culture, culture on selective media and polymerase chain reaction) will be used to determine S. aureus (MSSA or MRSA) carrier status. b. Decolonization: Decolonization will be done as follows i) Screening result Positive for MRSA and /or MSSA - 2% Intranasal mupirocin – BD x 5 days and 2% Chlorhexidine wipes – OD x 5 days before surgery ii) Screening negative or Non-carriers, 2% Chlorhexidine wipes, the night before and the morning of surgery Patients with negative screening results, but a documented history of MRSA carriage will be treated as a positive carrier regardless of the nares screening result. c. Optimized Peri-operative antimicrobial prophylaxis - The selection of antimicrobial agents to be used for perioperative prophylaxis will depend on patient’s S aureus carrier status. i) Non carriers and MSSA carriers will recieve Cefuroxime ii) MRSA carriers will recieve Cefuroxime and Vancomycin iii) Non carriers but with documented histories of MRSA carriage or infection will be treated as MRSA carriers. Note: For vancomycin allergy daptomycin in combination with cefuroxime (if not allergic to β-lactam) will be used. Patient with confirmed β-lactam allergy, vancomycin + gentamicin will be administered  
Comparator Agent  Current standard practice of our hospital  i) Preoperative bathing with plain soap on the day before and on the day of surgery. ii) Perioperative antimicrobial prophylaxis with cefuroxime only 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients posted for clean orthopedic surgery with hardware implants 
 
ExclusionCriteria 
Details  i) Patients under 18 years of age
ii) Patients who refuse to give informed consent
iii) Patients with revision and/or dirty surgeries
or with pre-existing infections at the
surgical site. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Establishment of Bundled intervention as a standard pre-operative preventive measure to reduce surgical site infections among patients undergoing clean orthopedic surgery with hardware implants.  To end of the study (09.10.22) 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To compare the incidence of surgical site infections between intervention group asnd control group.  To the end of the study (09.10.22) 
Costing of bundled intervention versus current standard practice/patient.  To end of the study (09.10.22) 
 
Target Sample Size   Total Sample Size="1720"
Sample Size from India="1720" 
Final Enrollment numbers achieved (Total)= "597"
Final Enrollment numbers achieved (India)="597" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 10/12/2019 
Date of Study Completion (India) 09/10/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

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.

 
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