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CTRI Number  CTRI/2023/06/054285 [Registered on: 21/06/2023] Trial Registered Prospectively
Last Modified On: 19/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   study of spread of infections in the surgical patients  
Scientific Title of Study   AN OBSERVATIONAL STUDY TO DETERMINE THE CAUSATIVE FACTORS AND TO ASSESS THE EFFECTIVENESS OF PRECAUTIONARY MEASURES FOR SURGICAL SITE INFECTION IN ELECTIVE GENERAL SURGICAL CASES 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shashank Singh 
Designation  POSTGRADUATE JUNIOR RESIDENT 
Affiliation  VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL, BANTHRA, SHAHJAHANPUR, UP, 242307 
Address  room number 178, department of general surgery, VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL , BANTHRA, SHAHJAHANPUR

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  8953592005  
Fax    
Email  shashankblah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishnu Sharma 
Designation  Professor 
Affiliation  VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL, BANTHRA, SHAHJAHANPUR, UP, 242307 
Address  room number 178, department of general surgery , Varun Arjun medical college and Rohilkhand hospital, Banthara

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  9719836000  
Fax    
Email  surgeryVAMC34@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shashank Singh 
Designation  POSTGRADUATE JUNIOR RESIDENT 
Affiliation  VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL, BANTHRA, SHAHJAHANPUR, UP, 242307 
Address  room number 178, department of general surgery ,VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL , BANTHRA, SHAHJAHANPUR

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  8953592005  
Fax    
Email  shashankblah@gmail.com  
 
Source of Monetary or Material Support  
varun arjun medical college and rohilkhand hospital, banthra ,shahjahanpur , uttar pradesh 242307 
 
Primary Sponsor  
Name  VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL 
Address  VARUN ARJUN MEDICAL COLLEGE AND ROHILKHAND HOSPITAL BANTHRA SHAHJAHANPUR UP 242307 
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 
shashank singh   Varun arjun medical college and Rohilkhand hospital  room number 178, department of general surgery , Banthara
Shahjahanpur
UTTAR PRADESH 
8953592005

shashankblah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION ETHICS COMMITEE , VAMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Only elective general surgical cases involving clean and clean contaminated surgeries will be taken up for study.
Both sexes will be included.
18 to 60 years age groups will be included.
Patients who are willing to be part of this study will be taken.
 
 
ExclusionCriteria 
Details  Immunocompromised patient
patients not willing to be part of the study
emergency surgeries
contaminated surgeries 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1-to know the risk factors and causes of SSIS
2-To know the prevalance of organisms isolated from SSIs and their sensitivity to various drugs
3-to identify the methods of prevention of SSIs
4-to have a protocol for treatment of SSIS 
3 weeks, 6 weeks, 9 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1-to DETERMINE RISK FACTORS PLAYING ROLE IN DEVELOPMENT OF SSI
2-To know the prevelance of organisms isolated from SSIs & their sensitivity to various drugs

3-TO POSTULATE A PROTOCOL FROM THE FINDINGS OF THE STUDY FOR PREVENTION AND TREATMENT OF SSIS
4-TO ASSESS MORBIDITY AND MORTALITY OF SSIs 
3weeks, 6weeks, 9 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   19/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
An elaborate study of the cases with regard to date of admission, history, clinical features date of surgery, type of surgery, emergency or elective, preoperative preparation and postoperative management will be done till patient is discharged from hospital, and then follow up the patient on OPD basis for any signs of wound infection for 1 year. 
The wounds will be examined for suggestive Signs/Symptoms of infection in the post-operative period, during wound dressing. In history, presenting complaints, duration, associated diseases, coexistent infections at a remote body site, personal history including diet, smoking, and alcoholism will be noted.  Post-operative findings which included day of wound infection, day of 1st dressing and frequency of change of dressing. 
Findings on the day of diagnosis of wound infection will be noted which includes fever, erythema, discharge, type and color and the exudates collected from the depth of the wound using sterile cotton swab and sent to microbiology department for culture and sensitivity. The specimens will be collected from patients with surgical site infection in wards/OT with a sterile stick with absorbent cotton swab and sent to the microbiology laboratory for bacterial culture and sensitivity to drugs. Blood investigation like CBC will be send and if required USG will be done.
 
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