| 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
|
|
|
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
|
|
|
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
- 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 - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [sagarikabalakrishna@gmail.com].
- 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.
- 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. |