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NCT Number: NCT00364741

Supplemental Oxygen and 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.

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Key information

Conditions

Laparotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus Sygehus, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older.
  • Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index >200 or a specimen with atypical or neoplastic cells).

Exclusion criteria

  • Other surgery within 30 days (except surgery in local anaesthesia).
  • Chemotherapy within 3 months.
  • Inability to give informed consent.
  • Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).

Treatment and study plan

Oxygen

Drug

During and 2 hours after surgery

Primary outcomes

  1. Surgical wound infection

    Time frame: 14 days after surgery

Secondary outcomes

  1. Atelectasis, pneumonia, respiratory insufficiency, second operation, mortality, length of postoperative hospitalization, admission to intensive care unit.

    Time frame: 30 days after surgery

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • The Danish Medical Research Council

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 16, 2006
Registry last updated
Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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