| CTRI Number |
CTRI/2025/09/095157 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see if adding local amikacin treatment to routine antibiotic injections helps better control surgical wound infections in a rural hospital |
|
Scientific Title of Study
|
To evaluate efficacy of local Amikacin therapy as an adjuvant to parental antibiotic in control of SSI compared to parental antibiotics alone in a rural hospital |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhiram Chadive |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Fourth Floor, Department of Surgery, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha
Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9110397246 |
| Fax |
|
| Email |
abhiramsai99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhiram Chadive |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Fourth Floor, Department of Surgery, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha
Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9110397246 |
| Fax |
|
| Email |
abhiramsai99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhiram Chadive |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Fourth Floor, Department of Surgery, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha
Sawangi, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9110397246 |
| Fax |
|
| Email |
abhiramsai99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College Datta Meghe Institute of Higher Education and Research |
| Address |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra, 442001 |
| Type of Sponsor |
Private 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 Abhiram Chadive |
Acharya Vinoba Bhave Rural Hospital |
Fourth Floor, Department of Surgery, Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha
Wardha
MAHARASHTRA |
9110397246
abhiramsai99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Parenteral antibiotics standard care |
Intravenous adult prophylactic dose as per hospital protocol according to body weight. Preoperative dose within 60 minutes before incision and postoperative dose upto 24 hours as per hospital protocol. |
| Intervention |
Parenteral antibiotics with local amikacin injection |
Intravenous as in comparator with local instillation of amikacin into wound based on body weight with total of two local. Single local instillation into subcutaneous wound cavity before skin closure intra operative. Single local instillation via subcutaneous drainage tube on postoperative day 3. IV antibiotics given same as control arm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients presenting to AVBRH with a case of clean and elective surgeries for abdominal surgeries
2) Patients between 18-74 years of age |
|
| ExclusionCriteria |
| Details |
1)Extremes of age less than 18 yrs and greater than 75yrs
2) Patients who are on immune-suppressants, chemo/radiotherapy, steroids other serious pre-existing
cardiovascular, pulmonary, and immunological disease.
3) Uncontrolled diabetic patients
4) Local infection |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-surgical infections are becoming a very common entity that can be easily avoided with proper usage of local antibiotic(Amikacin) along with parental antibiotics, we expect that the ASEPSIS scoring system will aid in proving the efficacy of local amikacin on operated site to prevent SSI |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of local Amikacin therapy as an adjuvant to parental antibiotic in control of SSI compared to parental antibiotics alone in a rural hospital |
2 years |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
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
|
It is a prospective interventional (simple randomized control study ) aimed at evaluating the efficacy of local use of amikacin therapy as an adjuvant to a parental antibiotic in control of SSI compared to parental antibiotics alone. SSI is becoming a fairly common occurrence in tertiary care hospitals which can be avoided and provide better prognostic relief and less hospital stay for the patient. ASEPSIS scoring system is used to differentiate and compare groups among local amikacin therapy and parental antibiotic versus parental antibiotics alone, using which a definitive comparative analysis can be derived for better clinical outcome
The current study aims to definitely prove the efficacy of using local amikacin therapy as an adjuvant to parental antibiotics in control of SSI compared to parental antibiotics alone in a rural hospital. |