Surgical Wound InfectionNCT00873704
Supplemental Oxygen in Vascular Surgery
A study testing supplemental postoperative oxygen in people with Surgical Wound Infection and Vascular Surgery, run by North Karelia Central Hospital at 6 sites in Finland.
Trial summary
The purpose of this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Surgical Wound Infection, Vascular Surgery
- What is being tested?
- supplemental postoperative oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 6 sitesFinland
- Study dates
- Mar 2009to Jun 2010
- Phase
- Interventional
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lower limb vascular surgery
Who cannot join
- COPD
- sPO2 less than 90%
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Finland6 sites
North Karelia Central Hospital
Joensuu, 80210
Central Finland Central Hospital
Jyväskylä, 40620
Kuopio University Hospital
Kuopio
South Karelia Central Hospital
Lappeenranta, 53130
Central Hospital of Mikkeli
Mikkeli, 50100
Lapland Central Hospital
Rovaniemi, 96101
About this study
Official title: Supplemental Postoperative Oxygen and the Risk of Surgical Wound Infection in a Vascular Surgery Population: A Randomized Controlled Trial
The purpose of this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery.
- Conditions
- Surgical Wound Infection, Vascular Surgery
- Being tested
- supplemental postoperative oxygen
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supplemental postoperative oxygenOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | recieves supplemental oxygen postoperatively Receives: Other: supplemental postoperative oxygen |
| 2 | No intervention | treated as usual without supplemental oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical wound infection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 274 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
- NCT00873704
- Sponsor's protocol ID
- NKCH-Surg-003
- Status last verified
- Oct 2015
- First submitted
- 31 Mar 2009
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
PubMed 41159585Turtiainen J, Saimanen EI, Partio TJ, Makinen KT, Reinikainen MT, Virkkunen JJ, Vuorio KS, Hakala T. Supplemental postoperative oxygen in the prevention of surgical wound infection after lower limb vascular surgery: a randomized controlled trial. World J Surg. 2011 Jun;35(6):1387-95. doi: 10.1007/s00268-011-1090-y.
PubMed 21476113
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Postoperative Oxygen and the Risk of Surgical Wound Infection in a Vascular Surgery Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00873704
- Acronym / sponsor ID
- NKCH-Surg-003
- Conditions
- Surgical Wound Infection, Vascular Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- North Karelia Central HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Apr 2009 (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 this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: supplemental postoperative oxygenrecieves supplemental oxygen postoperatively |
| 2 | No intervention | –treated as usual without supplemental oxygen |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lower limb vascular surgery
Key exclusion criteria (2 listed)
- COPD
- sPO2 less than 90%
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 |
|---|---|---|
| supplemental postoperative oxygen | Other | 1 |
Primary outcome
surgical wound infection
Time frame: 30 days
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 14 Oct 2015.
- Derived from this study: PubMed 41159585Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
- Derived from this study: PubMed 21476113Turtiainen J, Saimanen EI, Partio TJ, Makinen KT, Reinikainen MT, Virkkunen JJ, Vuorio KS, Hakala T. Supplemental postoperative oxygen in the prevention of surgical wound infection after lower limb vascular surgery: a randomized controlled trial. World J Surg. 2011 Jun;35(6):1387-95. doi: 10.1007/s00268-011-1090-y.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supplemental postoperative oxygen in people with Surgical Wound Infection and Vascular Surgery, run by North Karelia Central Hospital at 6 sites 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 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
surgical wound infection (time frame: 30 days). 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 NCT00873704, which also lists 2 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 14 Oct 2015.