Laparotomy Clinical Trial
Official title:
PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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