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Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Information source: Diskapi Teaching and Research Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Inguinal Hernia

Intervention: Gentamicin and cefazolin (Drug); Cefazolin (Drug); Gentamicin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Diskapi Teaching and Research Hospital

Official(s) and/or principal investigator(s):
Gaye E Seker, MD, Principal Investigator, Affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital
Duray Seker, MD, Study Director, Affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital
Bahattin Bayar, MD, Study Chair, Affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital
Zafer Ergul, MD, Study Chair, Affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital
Hakan Kulacoglu, Professor, Study Chair, Affiliation: Diskapi Yildirim Beyazit Teaching and research Hospital

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.

Clinical Details

Official title: Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome:

Rate of Post-operative Infection

Number of Infections in Each Study Arm

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

Minimum age: 16 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical diagnosis of inguinal hernia

Exclusion Criteria:

- Femoral hernia

- Emergency cases

Locations and Contacts

Diskapi Yildirim Beyazit Teaching and research Hospital, Ankara 06000, Turkey
Additional Information

Related publications:

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.

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.

Zuvela M, Milićević M, Galun D, Lekić N, Basarić D, Tomić D, Petrović M, Palibrk I. [Infection in hernia surgery]. Acta Chir Iugosl. 2005;52(1):9-26. Review. Serbian.

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.

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. Review.

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.

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.

Starting date: January 2011
Last updated: December 17, 2014

Page last updated: August 23, 2015

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