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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gentamicin | Active Comparator | 80 mg gentamicin topical application intraoperatively |
|
| Cefazolin | Active Comparator | Application of 1000 mg cefazolin intra venously 1 hour before surgery |
|
| gentamicin and cefazolin | Active Comparator | 1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentamicin and cefazolin | Drug | 80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Post-operative Infection | 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. | within the 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaye E Seker, MD | Diskapi Yildirim Beyazit Teaching and research Hospital | Principal Investigator |
| Duray Seker, MD | Diskapi Yildirim Beyazit Teaching and research Hospital | Study Director |
| Bahattin Bayar, MD | Diskapi Yildirim Beyazit Teaching and research Hospital | Study Chair |
| Zafer Ergul, MD | Diskapi Yildirim Beyazit Teaching and research Hospital | Study Chair |
| Hakan Kulacoglu, Professor | Diskapi Yildirim Beyazit Teaching and research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diskapi Yildirim Beyazit Teaching and research Hospital | Ankara | 06000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16860624 | Background | Pessaux P, Lermite E, Blezel E, Msika S, Hay JM, Flamant Y, Deepak V, Arnaud JP; French Associations for Surgical Research. Predictive risk score for infection after inguinal hernia repair. Am J Surg. 2006 Aug;192(2):165-71. doi: 10.1016/j.amjsurg.2006.05.003. | |
| 16930145 | Background | Tzovaras G, Delikoukos S, Christodoulides G, Spyridakis M, Mantzos F, Tepetes K, Athanassiou E, Hatzitheofilou C. The role of antibiotic prophylaxis in elective tension-free mesh inguinal hernia repair: results of a single-centre prospective randomised trial. Int J Clin Pract. 2007 Feb;61(2):236-9. doi: 10.1111/j.1742-1241.2006.00977.x. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gentamicin | Gentamicin arm: application of 80 mg gentamycin topically |
| FG001 | Cefazolin | Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery |
| FG002 | Gentamicin+ Cefazolin Sodium | Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gentamicin | Gentamicin arm: application of 80 mg gentamycin topically |
| BG001 | Cephazolin | Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Post-operative Infection | Not Posted | within the first 30 days after surgery | |||||||||||||
| Primary | Number of Infections in Each Study Arm | Patients were examined on postoperative 30 days for the presence of surgical site infection. | Posted | Number | infections | within the 30 days after surgery |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gentamicin | Gentamicin arm: application of 80 mg gentamycin topically Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose No adverse effect |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Gaye Seker | S.B.Ankara Diskapi Yildirim Beyazit Education and Teaching Hospital | +905323360618 | gayeebru@superonline.com |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005839 | Gentamicins |
| D002437 | Cefazolin |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D002511 | Cephalosporins |
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| Cefazolin | Drug | 1000 mg cefazolin application intravenously 1 hour before operation |
|
|
| Gentamicin | Drug | 80 mg gentamicin application intraoperatively |
|
|
| 16119310 | Background | Zuvela M, Milicevic M, Galun D, Lekic N, Basaric D, Tomic D, Petrovic M, Palibrk I. [Infection in hernia surgery]. Acta Chir Iugosl. 2005;52(1):9-26. doi: 10.2298/aci0501009z. Serbian. |
| 19321405 | Background | Praveen S, Rohaizak M. Local antibiotics are equivalent to intravenous antibiotics in the prevention of superficial wound infection in inguinal hernioplasty. Asian J Surg. 2009 Jan;32(1):59-63. doi: 10.1016/S1015-9584(09)60011-7. |
| 16252314 | Background | Aufenacker TJ, Koelemay MJ, Gouma DJ, Simons MP. Systematic review and meta-analysis of the effectiveness of antibiotic prophylaxis in prevention of wound infection after mesh repair of abdominal wall hernia. Br J Surg. 2006 Jan;93(1):5-10. doi: 10.1002/bjs.5186. |
| 20538079 | Background | Shankar VG, Srinivasan K, Sistla SC, Jagdish S. Prophylactic antibiotics in open mesh repair of inguinal hernia - a randomized controlled trial. Int J Surg. 2010;8(6):444-7. doi: 10.1016/j.ijsu.2010.05.011. Epub 2010 Jun 9. |
| 15570201 | Background | Aufenacker TJ, van Geldere D, van Mesdag T, Bossers AN, Dekker B, Scheijde E, van Nieuwenhuizen R, Hiemstra E, Maduro JH, Juttmann JW, Hofstede D, van Der Linden CT, Gouma DJ, Simons MP. The role of antibiotic prophylaxis in prevention of wound infection after Lichtenstein open mesh repair of primary inguinal hernia: a multicenter double-blind randomized controlled trial. Ann Surg. 2004 Dec;240(6):955-60; discussion 960-1. doi: 10.1097/01.sla.0000145926.74300.42. |
| BG002 | Gentamicin+ Cefazolin Sodium | Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Topical Gentamicin | Total number of patients to which topical gentamicin was applied for prophylaxis |
| OG001 | Cefazolin IV | Total number of patients to which ceephazoline (İV) was applied for prophylaxis |
| OG002 | Topical and iv | Total number of patients to which topical gentamicin and cephazoline (iv) was applied for prophylaxis |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| EG001 | Cephazolin | Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose No adverse effect | 0 | 98 | 0 | 98 |
| EG002 | Gentamicin+ Cefazolin Sodium | Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose No adverse effect | 0 | 91 | 0 | 91 |
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| D047090 |
| beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |