NCT00364741

Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial)

PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,400 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery. Background: Surgical wound infection is a common and serious complication. Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. Previous studies to test this hypothesis have shown entirely different results. Hence, the clinical decision between high and normal oxygen concentration is still controversial. Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery. Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery.

Conditions

• Laparotomy

Interventions

Type	Name	Description
DRUG	Oxygen	During and 2 hours after surgery

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2006-08-16
• Last updated: 2009-10-16

Locations

14 sites across 1 country: Denmark