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CTRI Number  CTRI/2024/04/066286 [Registered on: 25/04/2024] Trial Registered Prospectively
Last Modified On: 21/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive observational study 
Study Design  Other 
Public Title of Study   Microbiological profile of surgical site infections following surgical procedures in the department of obstetrics and gynaecology - a descriptive observational study 
Scientific Title of Study   Microbiological profile of surgical site infections following surgical procedures in the department of obstetrics and gynaecology- a descriptive observational study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shefali garg 
Designation  MS obstetrics and gynaecology 
Affiliation  Jawaharlal nehru medical college, KLE university  
Address  Department of obstetrics and gynaecology, Jawaharlal nehru medical college, Nehru nagar, KLE Hospital road Belgaum Karnataka 590010

Belgaum
KARNATAKA
590010
India 
Phone  9113553468  
Fax    
Email  shefalig.08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anita Dalal 
Designation  Professor 
Affiliation  Jawaharlal nehru medical college, KLE University 
Address  Department of obstetrics and gynaecology , Jawaharlal Nehru medical college, Nehru nagar, KLE Hospital road Belgaum KARNATAKA 590010

Belgaum
KARNATAKA
590010
India 
Phone  9448140343  
Fax    
Email  anitamgan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Shefali Garg 
Designation  MS obstetrics and gynaecology 
Affiliation  Jawaharlal nehru medical college, KLE University 
Address  Department of obstetrics and gynaecology , Jawaharlal Nehru medical college, Nehru nagar, KLE Hospital road Belgaum KARNATAKA 590010

Belgaum
KARNATAKA
590010
India 
Phone  9113553468  
Fax    
Email  shefalig.08@gmail.com  
 
Source of Monetary or Material Support  
KLEs Dr Prabhakar Kore hospital, Jawaharlal Nehru Medical College, KLE University , Belagavi 
 
Primary Sponsor  
Name  Jawaharlal Nehru medical college KLE University Belagavi 
Address  Department of obstetrics and gynaecology, Jawaharlal Nehru Medical College , KLE Hospital road, Belagavi, Karnataka , 590010 
Type of Sponsor  Private medical college 
 
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 Shefali Garg  KLEs Dr Prabhakar kore hospital, Belagavi  Department of obstetrics and gynaecology , Jawaharlal Nehru Medical College, Nehru nagar , KLE hospital road
Belgaum
KARNATAKA 
9113553468

shefalig.08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O989||Unspecified maternal infectious and parasitic disease complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  All the women undergoing surgical procedures in the department of obstetrics and gynaecology and developing surgical site infections.  
 
ExclusionCriteria 
Details  Surgical procedures done outside our hospital, admitted following

wound infections.

Women with wound infections occurring after 30 days of surgery.

Women declining for informed consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the microbiological profile of surgical site infections following surgical procedures  1yr hospital based study 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the incidence and risk factors for surgical site infections following surgical procedures   1 yr hospital based study 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Surgical site infection is defined as an infection occurring within 30 days after a surgical operation and affecting either incision er deep tissues at the operation site. These infections may be a superficial or deep incisional infection or infections

atvolving organ or body space. The need for the study is

1. Postoperative SSI is among the most common problems for patients who undergo surgical procedures. It is associated with increased morbidity,

mortality, prolonged hospital stay, secondary infertilay and increased economic costs for patient care

2. The incidence of pestoperative SSI varies widely between procedure, hospitals, surgeons, patients and geographical incations. There has been advance in SS1 control practices which include improved operating soom ventilation, sterilization methods, use of barriers, surgical techniques and availability of antimicrobial prophylaxis. Despite these, SSla still occur.

3. This is partly contributed by the emergence of antimicrobial resistant pathogenic hacteria. Reported risk factors for surgical site infection include emergency caesarean section, prolonged labour prior to caesarean section, prolonged rupture of membranes, multiple vaginal examinations, and prolonged abstracted labour Other factors are inadequate skills or poor technique of the surgeon, prolonged operating time, prolonged obstructed labour, postoperative anemia, high body mass index, diabetes mellitus, inanunosuppressive disorders and certain

modications like steroids.

Potential sources of infection idemified inchade anfihered an, amseptic

solutions, transporting of patients, surgical seam, over-crowding in theatre, theatre gowns, inadequately sterilised equipment, contaminated environment and grously contaminated surfaces.

Complications of SS1s include prolonged wound healing, wound dehiscence, wound pain, burst abdomen, necrotizing fasciitis and pelvic abscess. Others prolonged admission, a prolonged course of antibiotics, the possibility of re admission, secondary nepair surgery, incisional bernis, disfiguring scar, and in rare condition can lead to severe sepsis and mortality.

6. Surgical site infections also affects the physical, emotional, social and economic aspects of life
 
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