| CTRI Number |
CTRI/2025/01/079756 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on effect of antibiotic amikacin in patient undergoing surgery for perforation of bowel |
|
Scientific Title of Study
|
Amikacin Antibiotic prophylaxis in patient with perforation peritonitis :A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| subhash mishra |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhash Mishra |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Surgery Second floor Old block JIPMER Dhanvantri Nagar Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
subhashmishra764@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debasis Naik |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
Department of Surgery Second floor Old block JIPMER Dhanvantri Nagar Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
|
| Fax |
|
| Email |
debasismbbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhash Mishra |
| Designation |
Junior resident |
| Affiliation |
JIPMER |
| Address |
Department of Surgery Second floor Old block JIPMER Dhanvantri Nagar Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9241863682 |
| Fax |
|
| Email |
subhashmishra764@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Subhash mishra |
Jipmer hospital |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Subhash mishra |
Jawaharlal Institute of Postgraduate Medical Education and Research |
General surgery
Pondicherry
PONDICHERRY |
9241863682
subhashmishra764@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K650||Generalized (acute) peritonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amikacin Antibiotic prophylaxis in patient with perforation |
Only injection ceftriaxone 1gm and injection metronidazole 500mg will be administered intravenously |
| Intervention |
Amikacin Antibiotic prophylaxis in patient with perforation peritonitis:A Randomized Controlled Trial |
Injection amikacin 500mg will be administered intravenously along with injection ceftriaxone 1 GM and injection metronidazole 500 mg at the time of induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
|
|
| ExclusionCriteria |
| Details |
Renal failure
Immunosuppressed |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of superficial deep organ space infection in patient receiving amikacin in addition to the standard ceftriaxone and metronidazole with that of patient receiving only the standard protocol following laparotomy for perforation peritonitis |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Surgical site infection, wound dehiscence, readmission, reintervention |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
10/02/2025 |
| 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="3"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [subhashmishra764@gmail.com].
- For how long will this data be available start date provided 14-07-2024 and end date provided 12-12-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Surgical site infections encompass a range of superficial to deep wound infections that can occur following an operative procedure. Surgical site infections are preventable complication, responsible for substantial financial burden to health services that can result in poorer patient outcomes,increased mortality, morbidity and reoperation rates.purpose of this study is to explore the usefulness of an antibiotic (injection amikacin) in reducing the occurrence of infections at the site of surgery when used in patient undergoing surgery for perforation peritonitis. |