Inguinal Hernia
Conditions
Keywords
inguinal hernia, infection prophylaxis, topical gentamicin
Brief summary
Aim of this study is to measure the effectiveness of topical gentamicin to prevent post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is, if it is effective as a prophylactic agent, to compare it's effect with intra venous single dose cefazolin sodium prophylaxis.
Detailed description
This study is a single blind prospective randomized trial. To measure and compare the effectiveness intra-operative topical gentamicin application in tension-free inguinal hernia repair in contrast to intravenous peri-operative prophylactic cefazolin sodium and combination of gentamicin and cephazolin this study is designed. The patients are grouped randomly in to two groups: * Group1;intravenous cefazolin sodium * Group2;topical gentamicin * Group3:topical gentamicin and intravenous cefazolin sodium As a control group we decided to use the data of control groups ( without any prophylactic agent usage ) of previous studies done in our clinic and medical data base reviews.
Interventions
DRUGGentamicin and cefazolin
80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation
DRUGCefazolin
1000 mg cefazolin application intravenously 1 hour before operation
DRUGGentamicin
80 mg gentamicin application intraoperatively
Sponsors
Diskapi Teaching and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of inguinal hernia
Exclusion criteria
* Femoral hernia * Emergency cases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Post-operative Infection | within the first 30 days after surgery | — |
| Number of Infections in Each Study Arm | within the 30 days after surgery | Patients were examined on postoperative 30 days for the presence of surgical site infection. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Recruitment period begins in Jan 2011. This period will be completed when record of minimum number participants ( according to power analysis) in each arm is completed.Location is surgery clinic of our hospital.
Pre-assignment details
Totaly, 24 patients who were known using any kind of antibiotics for any reason just prior to surgery or just after the surgery and having history of allergic reactions to antibiotics used in this study were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Gentamicin Gentamicin arm: application of 80 mg gentamycin topically | 87 |
| Cephazolin Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery | 98 |
| Gentamicin+ Cefazolin Sodium Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively | 91 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 13 | 2 | 9 |
Baseline characteristics
| Characteristic | Cephazolin | Gentamicin+ Cefazolin Sodium | Gentamicin | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 20 Participants | 27 Participants | 80 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 71 Participants | 60 Participants | 196 Participants |
| Age, Continuous | 49.60 years STANDARD_DEVIATION 13.85 | 50.36 years STANDARD_DEVIATION 15.49 | 50.39 years STANDARD_DEVIATION 15.39 | 50.10 years STANDARD_DEVIATION 14.85 |
| Region of Enrollment Turkey | 98 participants | 91 participants | 87 participants | 276 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 93 Participants | 86 Participants | 80 Participants | 259 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 87 | 0 / 98 | 0 / 91 |
| serious Total, serious adverse events | 0 / 87 | 0 / 98 | 0 / 91 |
Outcome results
Primary
Number of Infections in Each Study Arm
Patients were examined on postoperative 30 days for the presence of surgical site infection.
Time frame: within the 30 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Topical Gentamicin | Number of Infections in Each Study Arm | 1 infections |
| Cefazolin IV | Number of Infections in Each Study Arm | 3 infections |
| Topical and iv | Number of Infections in Each Study Arm | 0 infections |
Comparison: Comparison Group Selection: our primary outcome is infection positive or negativeso, we compared the frequencies of being positive infections for these three groups. Our null hypothesis is positive infection frequencies are same for three groups. We calculated post-hoc power for this design and found 0.99 for the percentages which shows positive infections respectively for Topical Gentamicin, cefazoline iv and topical gentamicin and iv cefazolin; 2.3%, 3.1% and 0%.p-value: 0.198Fisher Exact
Primary
Rate of Post-operative Infection
Time frame: within the first 30 days after surgery