| 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 |
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Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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A randomised controlled study to compare the effect of antibiotic infiltration at the incision site, in preventing surgical site infections in emergency midline surgeries. |
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Scientific Title of Study
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COMPARISON OF EFFECT OF CEFTRIAXONE IN-FILTRATION BEFORE INCISION AND BEFORE CLOSURE IN LAPAROTOMY FOR PERFORATION PERITONITIS –A RANDOMIZED CONTROL STUDY.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| MAULANA AZAD MEDICAL COLLEGE |
|
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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 |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| 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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (2) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), |
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Intervention / Comparator Agent
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| 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. |
|
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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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
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| 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. |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Duration of hospital stay. |
Time duration |
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Target Sample Size
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Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
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Phase of Trial
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N/A |
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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 |
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Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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. |