NCT01273818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 29, 2014

Completed
Last Updated

December 29, 2014

Status Verified

September 1, 2014

Enrollment Period

2.1 years

First QC Date

January 10, 2011

Results QC Date

December 9, 2013

Last Update Submit

December 17, 2014

Conditions

Inguinal Hernia

Keywords

inguinal herniainfection prophylaxistopical gentamicin

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

gentamicin

ACTIVE COMPARATOR

80 mg gentamicin topical application intraoperatively

Drug: Gentamicin

Cefazolin

ACTIVE COMPARATOR

Application of 1000 mg cefazolin intra venously 1 hour before surgery

Drug: Cefazolin

gentamicin and cefazolin

ACTIVE COMPARATOR

1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively

Drug: Gentamicin and cefazolin

Interventions

Gentamicin and cefazolinDRUG

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
gentamicin and cefazolin
CefazolinDRUG

1000 mg cefazolin application intravenously 1 hour before operation

Also known as: Cezal, Eqizolin
Cefazolin
GentamicinDRUG

80 mg gentamicin application intraoperatively

Also known as: Gensif, Gentamed
gentamicin

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of inguinal hernia

You may not qualify if:

  • Femoral hernia
  • Emergency cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Teaching and research Hospital

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 16860624BACKGROUND

  • 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.

    PMID: 16930145BACKGROUND

  • 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.

    PMID: 16119310BACKGROUND

  • 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.

    PMID: 19321405BACKGROUND

  • 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.

    PMID: 16252314BACKGROUND

  • 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.

    PMID: 20538079BACKGROUND

  • 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.

    PMID: 15570201BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

GentamicinsCefazolin

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr.Gaye Seker
Organization
S.B.Ankara Diskapi Yildirim Beyazit Education and Teaching Hospital
gayeebru@superonline.com
+905323360618

Study Officials

  • 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

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Surgery

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 11, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

December 29, 2014

Results First Posted

December 29, 2014

Record last verified: 2014-09

Locations

TU(1)