Clinical trial NCT01273818: Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair
Official title: Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inguinal Hernia
Keywords: inguinal hernia
infection prophylaxis
topical gentamicin
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 276
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of inguinal hernia

Exclusion Criteria:

* Femoral hernia
* Emergency cases

Primary outcomes:
measure: Rate of Post-operative Infection
timeFrame: within the first 30 days after surgery
measure: Number of Infections in Each Study Arm
timeFrame: within the 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Diskapi Yildirim Beyazit Teaching and research Hospital
Study officials:
affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital
name: Gaye E Seker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital
name: Duray Seker, MD
role: STUDY_DIRECTOR
affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital
name: Bahattin Bayar, MD
role: STUDY_CHAIR
affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital
name: Zafer Ergul, MD
role: STUDY_CHAIR
affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital
name: Hakan Kulacoglu, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.