Lower Limb IschaemiaNCT01505738
Bacterial Growth in Vascular Surgery Wounds
An observational study of Lower Limb Ischaemia and Aneurysm, run by North Karelia Central Hospital at 1 site in Finland.
Trial summary
The amount and species of bacteria have been shown to have an effect in wound infections in several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery of facial area). In vascular surgery, wound infections are a common and expensive complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Ischaemia, Aneurysm
- What is being tested?
- bacterial samples
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2012to Nov 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 patients requiring lower limb vascular surgery due to ischaemic changes and/or lower limb aneurysms.
Who may be able to join
- need for lower limb vascular by-pass surgery
Who cannot join
- allergic to cefuroxime
- patients refusal to participate
Trial locations and contacts
1 site in 1 country.
Finland1 site
North Karelia Central Hospital, Clinic of Surgery
Joensuu, FIN-80210
About this study
Official title: The Effect of Bacterial Growth in Vascular Surgery Wounds to the Incidence of Postoperative Wound Infections
The amount and species of bacteria have been shown to have an effect in wound infections in several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery of facial area). In vascular surgery, wound infections are a common and expensive complication. The aim of the present study is to investigate the prevalence of bacteria in vascular surgery wounds perioperatively, and determine whether is correlates with the incidence of wound infections postoperatively.
- Conditions
- Lower Limb Ischaemia, Aneurysm
- Being tested
- bacterial samples
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacterial samplesOther
bacterial samples taken
| Study group | Role | What they receive |
|---|---|---|
| bacterial cultures | Bacterial samples are collected preoperatively from urine, nose and possible lower limb ischaemic wounds, perioperatively from inguinal area and wound edges, and twice postoperatively. In addition, in case of a wound infection, bacterial samples are taken for diagnosis as usual. Receives: Other: bacterial samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection
incidence of wound infection after lower limb vascular surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb IschaemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Karelia Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanna Kouhia, North Karelia Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505738
- Sponsor's protocol ID
- NKCH-Surg-009
- Status last verified
- Dec 2012
- First submitted
- 4 Jan 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bacterial Growth in Vascular Surgery Wounds to the Incidence of Postoperative Wound Infections
- ClinicalTrials.gov ID
- NCT01505738
- Acronym / sponsor ID
- NKCH-Surg-009
- Conditions
- Lower Limb Ischaemia, Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Jan 2012 (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 amount and species of bacteria have been shown to have an effect in wound infections in several fields of surgery (such as gastrointestinal and orthopaedic surgery and the surgery of facial area). In vascular surgery, wound infections are a common and expensive complication. The aim of the present study is to investigate the prevalence of bacteria in vascular surgery wounds perioperatively, and determine whether is correlates with the incidence of wound infections postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bacterial cultures | – | Other: bacterial samplesBacterial samples are collected preoperatively from urine, nose and possible lower limb ischaemic wounds, perioperatively from inguinal area and wound edges, and twice postoperatively. In addition, in case of a wound infection, bacterial samples are taken for diagnosis as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients requiring lower limb vascular surgery due to ischaemic changes and/or lower limb aneurysms.
Key inclusion criteria (1 listed)
- need for lower limb vascular by-pass surgery
Key exclusion criteria (2 listed)
- allergic to cefuroxime
- patients refusal to participate
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 |
|---|---|---|
| bacterial samplesbacterial samples taken | Other | bacterial cultures |
Primary outcome
wound infection
Time frame: 3 months
incidence of wound infection after lower limb vascular surgery
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 Dec 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Ischaemia and Aneurysm, run by North Karelia Central Hospital at 1 site in Finland.
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 17 Dec 2012. 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 Finland. 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.
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?
wound infection (time frame: 3 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 Dec 2012; AzTrials last refreshed its copy on 6 Nov 2026.