Inguinal HerniaPhase 4NCT01264003
Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias
A Phase 4 study testing sefazolin in people with Inguinal Hernia, run by Diskapi Teaching and Research Hospital.
Trial summary
Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when prosthetic materials are used. This prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- sefazolin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias
Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when prosthetic materials are used. This prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.
Read the detailed description
There are two group in the study. Control group received no antibiotic prohylaxis, whereas a single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the study. 30-days surgical site infection rates and 1 year prosthetic intervention late infection rates are observed and recorded. Side effects of antibiotic used are also recorded.
- Conditions
- Inguinal Hernia
- Being tested
- sefazolin
- Keywords
- inguinal hernia, antibiotic, prophylaxis
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sefazolinDrug
In prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Antibiotic prohylaxis / Lichtenstein repair Receives: Drug: sefazolin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Measured: 30 days postoperatively
Secondary outcomes (2)
Drug side effects
Measured: 5 days postoperatively
1-year prosthetic repair surgical site late infection rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264003
- Sponsor's protocol ID
- DEAH-1002-IHR
- Status last verified
- May 2008
- First submitted
- 20 Dec 2010
- Last updated
- 21 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Antibiotic Prophylaxis in Lihtenstein Repair for Primary Inguinal Hernias
- ClinicalTrials.gov ID
- NCT01264003
- Acronym / sponsor ID
- DEAH-1002-IHR
- Conditions
- Inguinal Hernia
- Keywords
- inguinal hernia, antibiotic, prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when prosthetic materials are used. This prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.
Detailed description
There are two group in the study. Control group received no antibiotic prohylaxis, whereas a single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the study. 30-days surgical site infection rates and 1 year prosthetic intervention late infection rates are observed and recorded. Side effects of antibiotic used are also recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: sefazolinAntibiotic prohylaxis / Lichtenstein repair |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| sefazolinIn prophylaxis | Drug | 1 |
Primary outcome
Surgical site infection
Time frame: 30 days postoperatively
2 secondary outcomes
Drug side effects
Time frame: 5 days postoperatively
1-year prosthetic repair surgical site late infection rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sefazolin in people with Inguinal Hernia, run by Diskapi Teaching and Research Hospital.
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 0 inclusion and 1 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 21 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Surgical site infection (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2010.