NCT00873704

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

March 31, 2009

Last Update Submit

October 11, 2015

Conditions

Surgical Wound InfectionVascular Surgery

Outcome Measures

Primary Outcomes (1)

  • surgical wound infection

    30 days

Study Arms (2)

1

ACTIVE COMPARATOR

recieves supplemental oxygen postoperatively

Other: supplemental postoperative oxygen

2

NO INTERVENTION

treated as usual without supplemental oxygen

Interventions

supplemental postoperative oxygenOTHER
1

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lower limb vascular surgery

You may not qualify if:

  • COPD
  • sPO2 less than 90%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

North Karelia Central Hospital

Joensuu, 80210, Finland

Location

Central Finland Central Hospital

Jyväskylä, 40620, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

South Karelia Central Hospital

Lappeenranta, 53130, Finland

Location

Central Hospital of Mikkeli

Mikkeli, 50100, Finland

Location

Lapland Central Hospital

Rovaniemi, 96101, Finland

Location

Related Publications (2)

  • 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.

    PMID: 41159585DERIVED

  • Turtiainen 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.

    PMID: 21476113DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 2, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

FI(6)