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NCT00873704 Clinical Trial

Supplemental Oxygen in Vascular Surgery

Surgical Wound Infection Clinical Trial

Official title:
Supplemental Postoperative Oxygen and the Risk of Surgical Wound Infection in a Vascular Surgery Population: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00873704
Other study ID # NKCH-Surg-003
Secondary ID
Status Completed
Phase N/A
First received March 31, 2009
Last updated October 11, 2015
Start date March 2009
Est. completion date June 2010

Study information
Verified date October 2015
Source North Karelia Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: North Karelia central hospital department of vascular surgery
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 274
Est. completion date June 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria:

- lower limb vascular surgery

Exclusion Criteria:

- COPD

- sPO2 less than 90%

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• supplemental postoperative oxygen

Locations
Country Name City State
Finland North Karelia Central Hospital Joensuu
Finland Central Finland Central Hospital Jyväskylä
Finland Kuopio University Hospital Kuopio
Finland South Karelia Central Hospital Lappeenranta
Finland Central Hospital of Mikkeli Mikkeli
Finland Lapland Central Hospital Rovaniemi

Sponsors (1)
Lead Sponsor Collaborator
North Karelia Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary surgical wound infection 30 days Yes
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