Inguinal HerniaPhase 4NCT01273818
Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair
A Phase 4 study testing Gentamicin and cefazolin, Cefazolin and Gentamicin in people with Inguinal Hernia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Gentamicin and cefazolin, Cefazolin and Gentamicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of inguinal hernia
Who cannot join
- Femoral hernia
- Emergency cases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Teaching and research Hospital
Ankara, 06000
About this study
Official title: Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study
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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Gentamicin and cefazolin, Cefazolin, Gentamicin
- Keywords
- inguinal hernia, infection prophylaxis, topical gentamicin
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentamicin and cefazolinDrug
Also called Drug: Cefazolin, Other names:, Cezol, Eqizolin
80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation
CefazolinDrug
Also called Cezal, Eqizolin
1000 mg cefazolin application intravenously 1 hour before operation
GentamicinDrug
Also called Gensif, Gentamed
80 mg gentamicin application intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| gentamicin | Active comparator | 80 mg gentamicin topical application intraoperatively Receives: Drug: Gentamicin |
| Cefazolin | Active comparator | Application of 1000 mg cefazolin intra venously 1 hour before surgery Receives: Drug: Cefazolin |
| gentamicin and cefazolin | Active comparator | 1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively Receives: Drug: Gentamicin and cefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Post-operative Infection
Measured: 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.
Measured: within the 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duray Seker, Diskapi Teaching and Research Hospital
- Investigators
- Gaye E Seker, MD, Principal investigator, Diskapi Yildirim Beyazit Teaching and research HospitalDuray Seker, MD, Study director, Diskapi Yildirim Beyazit Teaching and research HospitalBahattin Bayar, MD, Study chair, Diskapi Yildirim Beyazit Teaching and research HospitalZafer Ergul, MD, Study chair, Diskapi Yildirim Beyazit Teaching and research HospitalHakan Kulacoglu, Professor, Study chair, Diskapi Yildirim Beyazit Teaching and research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273818
- Sponsor's protocol ID
- FC-001
- Status last verified
- Sep 2014
- First submitted
- 10 Jan 2011
- Last updated
- 29 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 16860624Tzovaras 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.
PubMed 16930145Zuvela 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.
PubMed 16119310Praveen 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.
PubMed 19321405Aufenacker 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.
PubMed 16252314Shankar 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.
PubMed 20538079Aufenacker 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.
PubMed 15570201
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Topical Antibiotic Prophylaxis Effective in Lichtenstein Hernia Repair: a Comparison Study
- ClinicalTrials.gov ID
- NCT01273818
- Acronym / sponsor ID
- FC-001
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, infection prophylaxis, topical gentamicin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Posted 29 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| gentamicin | Active comparator | Drug: Gentamicin80 mg gentamicin topical application intraoperatively |
| Cefazolin | Active comparator | Drug: CefazolinApplication of 1000 mg cefazolin intra venously 1 hour before surgery |
| gentamicin and cefazolin | Active comparator | Drug: Gentamicin and cefazolin1000 mg cefazolin application 1 hour before surgery and topical 80 mg gentamicin intraoperatively |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of inguinal hernia
Key exclusion criteria (2 listed)
- Femoral hernia
- Emergency cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentamicin and cefazolinAlso: Drug: Cefazolin, Other names:, Cezol, Eqizolin80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation | Drug | gentamicin and cefazolin |
| CefazolinAlso: Cezal, Eqizolin1000 mg cefazolin application intravenously 1 hour before operation | Drug | Cefazolin |
| GentamicinAlso: Gensif, Gentamed80 mg gentamicin application intraoperatively | Drug | gentamicin |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16860624Pessaux 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.
- Background: PubMed 16930145Tzovaras 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.
- Background: PubMed 16119310Zuvela 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.
- Background: PubMed 19321405Praveen 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.
- Background: PubMed 16252314Aufenacker 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.
- Background: PubMed 20538079Shankar 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.
- Background: PubMed 15570201Aufenacker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaye E Seker, MD principal investigator
Diskapi Yildirim Beyazit Teaching and research Hospital
Duray Seker, MD study director
Diskapi Yildirim Beyazit Teaching and research Hospital
Bahattin Bayar, MD study chair
Diskapi Yildirim Beyazit Teaching and research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gentamicin and cefazolin, Cefazolin and Gentamicin in people with Inguinal Hernia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Post-operative Infection (time frame: within the first 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01273818, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2014.