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CTRI Number  CTRI/2020/07/026302 [Registered on: 02/07/2020] Trial Registered Prospectively
Last Modified On: 13/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomised controlled study to compare the effect of antibiotic infiltration at the incision site, in preventing surgical site infections in emergency midline surgeries. 
Scientific Title of Study   COMPARISON OF EFFECT OF CEFTRIAXONE IN-FILTRATION BEFORE INCISION AND BEFORE CLOSURE IN LAPAROTOMY FOR PERFORATION PERITONITIS –A RANDOMIZED CONTROL STUDY.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GAURAV KUMAR 
Designation  RESIDENT DOCTOR 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Room no. -229 BL TANEJA BLOCK MAULANA AZAD MEDICAL COLLEGE
2, BAHADUR SHAH ZAFAR MARG NEW DELHI-110002
New Delhi
DELHI
110002
India 
Phone  9990443411  
Fax    
Email  shankhvar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PAWAN LAL 
Designation  PROFESSOR 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Room no-229 BL TANEJA BLOCK MAULANA AZAD MEDICAL COLLEGE
2, BAHADUR SHAH ZAFAR MARG NEW DELHI-110002
New Delhi
DELHI
110002
India 
Phone    
Fax    
Email  pawanlal@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  PAWAN LAL 
Designation  PROFESSOR 
Affiliation  MAULANA AZAD MEDICAL COLLEGE 
Address  Room No.-229 BL TANEJA BLOCK MAULANA AZAD MEDICAL COLLEGE
2, BAHADUR SHAH ZAFAR MARG NEW DELHI-110002
North East
DELHI
110002
India 
Phone    
Fax    
Email  pawanlal@yahoo.com  
 
Source of Monetary or Material Support  
MAULANA AZAD MEDICAL COLLEGE 
 
Primary Sponsor  
Name  MAULANA AZAD MEDICAL COLLEGE 
Address  DEPARTMENT OF GENERAL SURGERY 2ND FLOOR B L TANEJA BLOCK MAULANA AZAD MEDICAL COLLEGE NEW DELHI 110002 
Type of Sponsor  Government 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 GAURAV KUMAR  MAULANA AZAD MEDICAL COLLEGE  2, BAHADUR SHAH ZAFAR MARG NEW DELHI 110002
New Delhi
DELHI 
9990443411

shankhvar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (2) ICD-10 Condition: K631||Perforation of intestine (nontraumatic),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ceftriaxone infiltration before incision and before closure in laprotomy for perforation peritonitis.  Comparison of effect of ceftriaxone infiltration before incision and before closure in laprotomy for perforation peritonitis.  
Comparator Agent  Infiltration of normal saline.  Infiltration of normal saline. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patients diagnosed with perforation peritonitis. 
 
ExclusionCriteria 
Details  Diabetes Mellitus.
On immunosuppresive therapy.
BMI > 35 Kg/m2
Sensitivity to ceftriaxone.
Previous midline abdominal surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of ceftriaxone infiltration before incision and before closure in preventing SSI  Effect of ceftriaxone infiltration before incision and before closure in preventing SSI on postoperative day 7. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of hospital stay.  Time duration 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/07/2020 
Date of Study Completion (India) 17/12/2021 
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)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Surgical site infection (SSI) continues to be a baffling problem. It is one of the major causes for postoperative morbidity and mortality. Over the years, reasonable success has been achieved in this direction by taking various aseptic measures, which were initiated by Joseph Lister  in 1860.

1 Initially, the antibiotics were only administered post-operatively for treatment of already established surgical site infection.

2 Later, the concept of antibiotic prophylaxis was introduced. After administration of intravenous (IV) antibiotic, there is distribution of antibiotics, initially in the systemic pool and then in the peripheral pool, which results in a low concentration of the antibiotic at the site where it is needed the most.

3 Therefore, the search for alternative modes of administration of prophylactic antibiotics was started so as to affect a further decrease in the rate of wound infection. One such method is the intra-incisional infiltration of prophylactic antibiotics. This mode ensures a high concentration of antibiotic at the incision site and it has been proven to provide systemic cover by the absorption of the antibiotic from the incision site. Ceftriaxone an antibiotic with long half-life, was chosen because of its known effectiveness against a wide range of wound pathogens, including obligate anaerobes, at concentrations likely to be present locally. This study is done to evaluate the role of intra incisional infiltration of ceftriaxone in prevention of SSI.

 
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