NCT00364741

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2006

Typical duration for phase_4

Geographic Reach
1 country

14 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

First Submitted

Initial submission to the registry

August 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

2 years

First QC Date

August 15, 2006

Last Update Submit

October 15, 2009

Conditions

Laparotomy

Outcome Measures

Primary Outcomes (1)

  • Surgical wound infection

    14 days after surgery

Secondary Outcomes (1)

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

    30 days after surgery

Study Arms (2)

A

ACTIVE COMPARATOR

Fraction of inspired oxygen (FiO2) = 0.30

Drug: Oxygen

B

ACTIVE COMPARATOR

FiO2 = 0.80

Drug: Oxygen

Interventions

OxygenDRUG

During and 2 hours after surgery

AB

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Aarhus Sygehus

Aarhus, DK-8000, Denmark

Location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Copenhagen University Hospital, Amager

Copenhagen, DK-2300, Denmark

Location

Copenhagen University Hospital, Bispebjerg

Copenhagen, DK-2400, Denmark

Location

Copenhagen University Hospital, Gentofte

Hellerup, DK-2900, Denmark

Location

Copenhagen University Hospital, Herlev

Herlev, DK-2730, Denmark

Location

Holbaek Hospital

Holbæk, DK-4300, Denmark

Location

Kolding Hospital

Kolding, DK-6000, Denmark

Location

Nykoebing Falster Hospital

Nykoebing Falster, DK-4800, Denmark

Location

Naestved Hospital

Næstved, DK-4700, Denmark

Location

Slagelse Hospital

Slagelse, DK-4200, Denmark

Location

Funen County Hospital

Svendborg, DK-5700, Denmark

Location

Vejle Hospital

Vejle, DK-7100, Denmark

Location

Viborg Hospital

Viborg, DK-8800, Denmark

Location

Related Publications (2)

  • Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Simonsen I, Pulawska T, Walker LR, Skovgaard N, Helto K, Gocht-Jensen P, Carlsson PS, Rask H, Karim S, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial. Trials. 2008 Oct 22;9:58. doi: 10.1186/1745-6215-9-58.

    PMID: 18945347BACKGROUND

  • Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.

    PMID: 19826023RESULT

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Lars S. Rasmussen, MD,DMSc,PHD

    Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

    STUDY CHAIR

  • Jørn Wetterslev, MD, PHD

    Copenhagen Trial Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

    STUDY DIRECTOR

  • Lars N. Jørgensen, MD, DMSc

    Dept. of Surgery, Copenhagen University Hospital, Bispebjerg, Copenhagen, Denmark

    STUDY DIRECTOR

  • Christian S. Meyhoff, MD, PhD

    Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 16, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

DK(14)