| CTRI Number |
CTRI/2025/08/092975 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Wound Infections After Emergency Belly Surgery in patients coming to surgery emergency With or Without Using Antibiotic Under the Skin |
|
Scientific Title of Study
|
Comparison of surgical site infections with or without subcutaneous amikacin in patients of emergency laparotomy- A Randomised Controlled 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 Rahul Kumar |
| Designation |
Post Graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Surgery Emergency 3 Floor gate no. 4 Delhi gate Metro Station Central, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi, Delhi 110002 Loknayak hospital
Central
DELHI
110002
India |
| Phone |
9310479727 |
| Fax |
|
| Email |
9871052707r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PAWAN LAL |
| Designation |
Director professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
BL TANEJA block maulana azad medical college Delhi gate Metro Station Central, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi, Delhi 110002 Loknayak hospital
Central
DELHI
110002
India |
| Phone |
9968604405 |
| Fax |
|
| Email |
pawanlal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Kumar |
| Designation |
Post Graduate |
| Affiliation |
Maulana Azad Medical College |
| Address |
Surgery Emergency 3 Floor gate no. 4 Delhi gate Metro Station Central, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi, Delhi 110002 Loknayak hospital
Central
DELHI
110002
India |
| Phone |
9310479727 |
| Fax |
|
| Email |
9871052707r@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, Lok Nayak Hospital , delhi 110002 , INDIA |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Surgery Emergency 3 Floor gate no. 4 Delhi gate Metro Station Central, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi, Delhi 110002 Loknayak hospital |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Kumar |
Lok Nayak Hospital |
Surgery Emergency 3 Floor gate no. 4 Delhi gate Metro Station Central, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi, Delhi 110002 Loknayak hospital
Central
DELHI |
9873020997
9871052707r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad medical college and associated hospitals, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exploratory laparotomy with subcutaneous injection of amikacin |
Amikacin belong to aminoglycoside group of antibiotics with long half-life, was chosen because of its known effectiveness against a wide range of wound pathogens, including gram negative bacteria and multi drug resistance organisms, at concentrations likely to be present locally. Amikacin has good penetration into most tissues thus local effect is more as has less metabolism in body. This study is done to evaluate the role of subcutaneous infiltration of amikacin in prevention of surgical site infection.total duration of intervention will be around 1 minute |
| Comparator Agent |
Exploratory laparotomy without amikacin |
An exploratory laparotomy is a surgical procedure in which a surgeon makes an incision in the abdominal wall to visually examine the abdominal organs. It is typically performed when the cause of abdominal pain or disease is unclear and other diagnostic methods have not provided sufficient information. This procedure allows the surgeon to directly inspect organs such as the stomach, intestines, liver, and others to diagnose or treat conditions like internal bleeding, tumors, or infections. When noted as "without amikacin," it means that the antibiotic amikacin, which is often used to treat or prevent bacterial infections, was not administered during or after the procedure. This may be due to the absence of infection risk, the use of alternative antibiotics, or concerns about potential side effects such as kidney toxicity associated with amikacin use. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients presenting to surgery emergency who are undergoing exploratory laparotomy |
|
| ExclusionCriteria |
| Details |
Hyperbilirubinemia
Not able to close abdomen
Acute kidney disease
Chronic kidney disease
Immunocompromised state |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients in whom surgical site infection as defined by grade 2 CDC criteria |
2nd day, 4th day, 7th day , 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of wound dehiscence
2. Duration of hospital stay in days |
3rd day,1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [9871052707r@gmail.com].
- For how long will this data be available start date provided 06-02-2025 and end date provided 08-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A combination of antimicrobial therapy improved surgical technique and intensive care support may improve the outcome of such cases In cases of perforation peritonitis abdominal closure is sometimes challenging to the surgeon where bowel become oedematous in severe peritonitis. There will be outpouring of fluid or pus from peritoneal cavity to the surgical wound subcutaneous tissues that can lead to wound infection and wound dehiscence. If the wound kept open then there is high risk for developing nosocomial infection. Incisional surgical site infection causes increasing patient suffering and a decreased quality of life.
|