A Phase 4 interventional study of Gentamicin and cefazolin and Cefazolin in Inguinal Hernia, sponsored by Diskapi Teaching and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-29.
Sponsored by Diskapi Teaching and Research Hospital · Phase 4, Interventional, and Prevention
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.
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:
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.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 276 is above the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Diskapi Teaching and Research Hospital is the lead sponsor of 101 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
80 mg gentamicin topical application intraoperatively
Drug: Gentamicin
Application of 1000 mg cefazolin intra venously 1 hour before surgery
Drug: Cefazolin
1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively
Drug: Gentamicin and cefazolin
80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation
Also known as: Drug: Cefazolin, Other names:, Cezol, Eqizolin, Drug: Gentamicin, Gensif, Gentamed
1000 mg cefazolin application intravenously 1 hour before operation
Also known as: Cezal, Eqizolin
80 mg gentamicin application intraoperatively
Also known as: Gensif, Gentamed
Rate of Post-operative Infection
Time frame: within the first 30 days after surgery
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
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.
| Milestone | Gentamicin | Cefazolin | Gentamicin+ Cefazolin Sodium |
|---|---|---|---|
| Started | 100 | 100 | 100 |
| Completed | 87 | 98 | 91 |
| Not completed | 13 | 2 | 9 |
| Withdrew: Physician decision | 13 | 2 | 9 |
Results for this outcome have not been posted.
Patients were examined on postoperative 30 days for the presence of surgical site infection.
| infections | Topical Gentamicin | Cefazolin IV | Topical and iv |
|---|---|---|---|
| Number of Infections in Each Study Arm | 1 | 3 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gentamicin | — | 0/87 (0%) | 0/87 (0%) |
| Cephazolin | — | 0/98 (0%) | 0/98 (0%) |
| Gentamicin+ Cefazolin Sodium | — | 0/91 (0%) | 0/91 (0%) |
300 consequtive patients were diveded into three groups randomly, but during follow-up period since 24 patients used any kind of antibiotics for reasons other than postoperative complications, only 276 patients were analyzed.
| Age, Categorical(Participants) | Gentamicin | Cephazolin | Gentamicin+ Cefazolin Sodium | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 60 | 65 | 71 | 196 |
| >=65 years | 27 | 33 | 20 | 80 |
| Age, Continuous(years) | Gentamicin | Cephazolin | Gentamicin+ Cefazolin Sodium | Total |
|---|---|---|---|---|
| Mean | 50.39 ± 15.39 | 49.60 ± 13.85 | 50.36 ± 15.49 | 50.10 ± 14.85 |
| Sex: Female, Male(Participants) | Gentamicin | Cephazolin | Gentamicin+ Cefazolin Sodium | Total |
|---|---|---|---|---|
| Female | 7 | 5 | 5 | 17 |
| Male | 80 | 93 | 86 | 259 |
| Region of Enrollment(participants) | Gentamicin | Cephazolin | Gentamicin+ Cefazolin Sodium | Total |
|---|---|---|---|---|
| Turkey | 87 | 98 | 91 | 276 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Diskapi Teaching and Research Hospital