| CTRI Number |
CTRI/2025/08/092216 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In a patient operated for acute appenidicitis,this trial compares the infection rates at surgical sites in patients given wash with antibiotic or with saline |
|
Scientific Title of Study
|
Evaluation of surgical site infection rates
RATES with or without metronidazole wound irrigation in appendicectomy for acute appendicitis -A randomised control 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 |
Deepinder Kaur |
| Designation |
Post Graduate student |
| Affiliation |
Maulana azad medical college and lok nayak hospital ,Delhi |
| Address |
Department of general surgery,2nd floor,BLT,Lok nayak hospital ,Delhi
New Delhi
DELHI
110002
India |
| Phone |
9877640910 |
| Fax |
|
| Email |
kaurdeepinder5721@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Director Professor Dr Sushanto Neogi |
| Designation |
Director professor |
| Affiliation |
Maulana azad medical college and lok nayak hospital ,Delhi |
| Address |
Department of general surgery,2nd floor,BLT,Lok nayak hospital ,Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604384 |
| Fax |
|
| Email |
sushantoneogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepinder Kaur |
| Designation |
Post Graduate student |
| Affiliation |
Maulana azad medical college and lok nayak hospital ,Delhi |
| Address |
Department of general surgery ,2nd floor,BLT,Lok nayak hospital ,Delhi
New Delhi
DELHI
110002
India |
| Phone |
9877640910 |
| Fax |
|
| Email |
kaurdeepinder5721@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok nayak hospital and maulana azad medical college ,near delhi gate ,new delhi ,Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana azad medical college |
| Address |
Maulana azad medical college and lok nayak hospital ,Delhi |
| 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 Deepinder Kaur |
Maulana azad medical college |
Room no 329,LNRDH hostel,Lok nayak hospital ,Delhi
New Delhi
DELHI |
09877640910
kaurdeepinder5721@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Metronidazole wash in open appedicectomy |
Metronidazole wash(100ml) given after closing external oblique for 1 minute in open appendicectomy performed in case of acute appedicitis |
| Comparator Agent |
Saline wash in open appendicectomy |
Saline wash(100ml) given after closing external oblique for 1 minute in open appendicectomy performed in case of acute appendicitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Only inclusion criteria include age |
|
| ExclusionCriteria |
| Details |
Pregnancy,lactation and immunocompromised states |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Surgical site infection rates based on CDDC criteria within 1 month.
|
At baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association of wound culture with the intraperitoneal fluid culture.
|
At baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
13/08/2025 |
| 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="2"
Days="20" |
|
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
|
This trial tests the comparison of rates of metronidazole wash after emergency appendicectomy with normal saline wash in a patient of acute appendicitis.Metronidazole wash is given after closure of external oblique,Single dose prophylactic antibiotic is given before open appendicectony to see the sole effect of wash on rates of surgical site infection.This trial also compares intraoperative and post operative cultures . |