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CTRI Number  CTRI/2025/08/092424 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of Topical Gentamicin in elective inguinal hernia surgery to prevent surgical site infection 
Scientific Title of Study   Efficacy of Topical Gentamicin with single dose IV Ceftriaxone versus single dose IV Ceftriaxone in the prevention of Surgical Site Infection after open prosthetic inguinal hernia repair; A 1-year Randomized control trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sagarika B 
Designation  Post graduate in general surgery 
Affiliation  Jawaharlal nehru medical college 
Address  Room number 215, New PG girls hostel,JNMC KLE university Campus
Nehrunagar
Belgaum
KARNATAKA
590010
India 
Phone  9449496949  
Fax    
Email  sagarikabalakrishna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashant Hombal 
Designation  Associate Professor 
Affiliation  Jawaharlal nehru medical college 
Address  Department of genral surgery, JNMC campus
Nehrunagar
Belgaum
KARNATAKA
590010
India 
Phone  6364506981   
Fax    
Email  hombalp@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Sagarika B 
Designation  Post graduate in general surgery 
Affiliation  Jawaharlal nehru medical college 
Address  Room no 215, New PG girls hostel, JNMC KLE university Campus
Nehrunagar

KARNATAKA
590010
India 
Phone  9449496949  
Fax    
Email  sagarikabalakrishna@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical college, Nehrunagar, Belagavi-590010 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical college 
Address  Nehrunagar,Belagavi-590010 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sagarika B  Jawaharlal Nehru Medical college  Department of General Surgery, JNMC campus, Nehrunagar, belagavi
Belgaum
KARNATAKA 
9449496949

sagarikabalakrishna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Single dose IV ceftriaxone in elective inguinal hernia surgery  Single dose 1 gm IV Ceftriaxone is given 30 mins before surgery 
Intervention  Topical use of gentamicin in elective inguinal hernia surgery along with IV ceftriaxone  In 100 ml NS 80 mg of gentamicin is taken in a bowl and the mesh is soaked in there for 10 mins and then the mesh is placed and wash is given with the remaining solution before closure of aponeurosis 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  Age 18-60, ASA grade 1 to 2, unilateral hernia, reducible hernia, no comorbidities 
 
ExclusionCriteria 
Details  acute kidney injury, chronic kidney disease, bilateral inguinal hernia, cardiac conditions,serum creatinine >1.3,irreducible hernia 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of Topical Gentamycin with single dose IV Ceftriaxone intraoperatively in patients undergoing elective Unilateral Lichtenstein inguinal hernia mesh repair in prevention of Surgical site infection.  The outcome is checked on post op day-0, 3, 7, 10 
 
Secondary Outcome  
Outcome  TimePoints 
Infection  1 year 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   08/08/2025 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sagarikabalakrishna@gmail.com].

  6. For how long will this data be available start date provided 30-04-2025 and end date provided 14-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

A hernia is defined as the abnormal protrusion of a viscus or a part of it through a weak point in the body. Inguinal hernia occurs either through the deep inguinal ring (indirect hernia) or through the posterior wall of the inguinal canal (direct hernia). Due to its low recurrence rates and convenience of use, the Lichtenstein tension-free inguinal hernia repair using polypropylene mesh is the preferred method; as a result, the usage of prosthetic mesh for inguinal repair has significantly expanded .

 

      Surgical site infections (SSI) are infections present in any location along the surgical tract after a surgical procedure. By definition, they can occur anytime from 0 to 30 days after the operation or upto 1 year after a procedure that has involved the implantation of a foreign material. It involves postoperative infections occurring at any level (incisional or deep) of a specific procedure. They are divided into a) Incisional superficial (skin, subcutaneous) b) Incisional deep (fascial plane and muscles) c) Organ/ space related (anatomical procedure of the procedure itself) .

 

      SSI is the most frequent complication in inguinal hernioplasty. It is a bothersome complication for both surgeons and patients since it wastes time and money and accounts for 20% of all healthcare-associated infections . General hospitals, especially centers who receive every kind of surgical case, including trauma and contaminated cases, may have SSI rates >5%. Although inguinal hernia repair is a clean surgical treatment with an average surgical site infection rate of less than 2% in hernia center hospitals, each institution has its own infection rate, and many of them are unable to achieve such a low rate .

 

     When repairing an inguinal hernia, first- or second-generation cephalosporins are typically administered intravenously prior to skin incision as antimicrobial prophylaxis . While this prophylactic can reduce the SSI rate, in many locations the SSI rate still exceeds 2% even with intravenous antibiotic prophylaxis. Topical antibiotics have been employed for the treatment of infected wounds. Commonly used antibiotics for topical prophylaxis are cephalosporins, aminoglycosides, glycopeptides, chloramphenicol and bacitracin.

 

   Gentamycin is an amino-sugar linked by a glycosidic bond to a central aminocyclitol ring . It inhibits the growth of bacteria in a concentration-dependent manner, regardless of the size of the inoculum, by first diffusing passively through the outer membrane of the bacterial pores and then crossing the membrane by an energy-dependent mechanism. It attaches to the 30 ribosomal subunit after it enters the cytoplasm, causing incorrect mRNA codon reading and the incorrect amino acids to be integrated into bacterial proteins. The killing effect of gentamycin is concentration-dependent and is followed by a bacteriostatic effect. It is primarily efficient against Gram-negative bacteria, although it also has the ability to kill staphylococci, which includes S. aureus and S. epidermidis. At the concentration used, it would be bactericidal and not bacteriostatic and it shows antimicrobial synergy when used in combination with B-Lactams.

 

      Applying topical antibiotics enables the use of a concentration that is significantly higher than systemic injection. Thus, resistance to antibiotics brought on by low drug dosage is prevented. The blood concentration of antibiotics stays low, lowering ototoxicity and nephrotoxicity, while the local drug concentrations are maintained for at least 48 hours. It is able to improve collagen type I/III ratio, scar ratio and mesh integration, thus help in faster wound healing and fibrin formation.

 

       Even though inguinal hernia surgery is a clean surgery, the surgical site infection is around 5-8% in a tertiary care centre, and this study might potentially help to reduce the SSI < 2% and thus helps achieving the perfect surgical outcome in a effective and feasible manner and thus leading to an excellent patient care and also the inconvenience caused by the SSI by using topical gentamicin.

 
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