Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01273818

Recruitment Status : Completed

First Posted : January 11, 2011

Results First Posted : December 29, 2014

Last Update Posted : December 29, 2014

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Duray Seker, Diskapi Teaching and Research Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Inguinal Hernia	Drug: Gentamicin and cefazolin Drug: Cefazolin Drug: Gentamicin	Phase 4

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.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	276 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Prevention
Official Title:	Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study
Study Start Date :	January 2011
Actual Primary Completion Date :	February 2013
Actual Study Completion Date :	March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Drug Information available for: Gentamicin Gentamicin sulfate Cefazolin Cefazolin sodium

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: gentamicin 80 mg gentamicin topical application intraoperatively	Drug: Gentamicin 80 mg gentamicin application intraoperatively Other Names: Gensif Gentamed
Active Comparator: Cefazolin Application of 1000 mg cefazolin intra venously 1 hour before surgery	Drug: Cefazolin 1000 mg cefazolin application intravenously 1 hour before operation Other Names: Cezal Eqizolin
Active Comparator: gentamicin and 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 Other Names: Drug: Cefazolin Other names: Cezol Eqizolin Drug: Gentamicin Gensif Gentamed

Outcome Measures

Primary Outcome Measures :

Rate of Post-operative Infection [ Time Frame: within the first 30 days after surgery ]
Number of Infections in Each Study Arm [ Time Frame: within the 30 days after surgery ]
Patients were examined on postoperative 30 days for the presence of surgical site infection.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	16 Years to 80 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of inguinal hernia

Exclusion Criteria:

Femoral hernia
Emergency cases

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273818

Locations

Layout table for location information

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

Sponsors and Collaborators

Diskapi Teaching and Research Hospital

Investigators

Layout table for investigator information

Principal Investigator:	Gaye E Seker, MD	Diskapi Yildirim Beyazit Teaching and research Hospital
Study Director:	Duray Seker, MD	Diskapi Yildirim Beyazit Teaching and research Hospital
Study Chair:	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

More Information

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. doi: 10.1016/j.amjsurg.2006.05.003.

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.

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.

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. doi: 10.1002/bjs.5186.

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. doi: 10.1097/01.sla.0000145926.74300.42.

Layout table for additonal information

Responsible Party:	Duray Seker, M.D. Surgery, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:	NCT01273818
Other Study ID Numbers:	FC-001
First Posted:	January 11, 2011 Key Record Dates
Results First Posted:	December 29, 2014
Last Update Posted:	December 29, 2014
Last Verified:	September 2014

Keywords provided by Duray Seker, Diskapi Teaching and Research Hospital:


inguinal hernia infection prophylaxis topical gentamicin

Additional relevant MeSH terms:

Layout table for MeSH terms

Hernia Hernia, Inguinal Pathological Conditions, Anatomical Hernia, Abdominal Gentamicins Cefazolin	Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

To Top