Surgical Wound InfectionPhase 4NCT00530400
Study of the Efficacy of Preoperative Cefuroxime Prophylaxis to Prevent Surgical Site Infection in Herniated Disk Surgery
A Phase 4 study testing cefuroxime in people with Surgical Wound Infection, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
Trial summary
The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- cefuroxime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,369 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 1994to Mar 2000
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18
- spinal surgery for herniated disk
Who cannot join
- known or suspected hypersensitivity to cephalosporins
- type I hypersensitivity to betalactamic antibiotics
- severe renal function impairment
- acquired immune deficiency syndrome (AIDS) or other conditions of severe immuno-suppression
- antibiotic therapy for concomitant infection at the time of surgery
- pregnancy
- refusal to participate
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Hôpitaux Universitaire de Genève
Geneva, 1211
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
About this study
Official title: Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery
The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk
- Conditions
- Surgical Wound Infection
- Being tested
- cefuroxime, placebo
- Keywords
- Antibiotic prophylaxis, Bacterial Infections / prevention & control, Surgical wound infection / prevention & control, Neurosurgery, Postoperative Complications / prevention & control, Clinical trial [publication type]
- Medical subject headings
- Surgical Wound Infection, Bacterial Infections, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefuroximeDrug
preoperative intravenous 1.5g cefuroxime
placeboDrug
preoperative intravenous placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | intravenous 1.5g cefuroxime Receives: Drug: cefuroxime |
| 2 | Placebo comparator | intravenous placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a surgical site infection
Measured: 6 months
Secondary outcomes (2)
Occurrence of a post-operative infection other than surgical site infection
Measured: 6 monts
Serious adverse event
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startApr 1994
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, GlaxoSmithKline
- Investigators
- Patrick Francioli, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530400
- Sponsor's protocol ID
- CFX93LS06
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2007
- Last updated
- 17 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-Blind, Randomized, Placebo-Controlled Trial of Single-Dose Cefuroxime Prophylaxis in Herniated Disk Surgery
- ClinicalTrials.gov ID
- NCT00530400
- Acronym / sponsor ID
- CFX93LS06
- Conditions
- Surgical Wound Infection
- Keywords
- Antibiotic prophylaxis, Bacterial Infections / prevention & control, Surgical wound infection / prevention & control, Neurosurgery, Postoperative Complications / prevention & control, Clinical trial [publication type]
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,369 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, GlaxoSmithKline
- Study start
- Apr 1994
- Study completion
- Mar 2000 (actual)
- First posted
- 17 Sep 2007 (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.
The purpose of the study is to determine whether a single, pre-operative dose of cefuroxime is effective in preventing surgical site infection in patients undergoing surgery for herniated disk
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: cefuroximeintravenous 1.5g cefuroxime |
| 2 | Placebo comparator | Drug: placebointravenous placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age older than 18
- spinal surgery for herniated disk
Key exclusion criteria (7 listed)
- known or suspected hypersensitivity to cephalosporins
- type I hypersensitivity to betalactamic antibiotics
- severe renal function impairment
- acquired immune deficiency syndrome (AIDS) or other conditions of severe immuno-suppression
- antibiotic therapy for concomitant infection at the time of surgery
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 |
|---|---|---|
| cefuroximepreoperative intravenous 1.5g cefuroxime | Drug | 1 |
| placebopreoperative intravenous placebo | Drug | 2 |
Primary outcome
Occurrence of a surgical site infection
Time frame: 6 months
2 secondary outcomes
Occurrence of a post-operative infection other than surgical site infection
Time frame: 6 monts
Serious adverse event
Time frame: 6 months
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 17 Sep 2007.
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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.
Patrick Francioli, MD principal investigator
Centre Hospitalier Universitaire Vaudois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cefuroxime in people with Surgical Wound Infection, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
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 2 inclusion and 7 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 17 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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?
Occurrence of a surgical site infection (time frame: 6 months). 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 17 Sep 2007.