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| ID | Type | Description | Link |
|---|---|---|---|
| GCP-2006-101 | |||
| KF 02 306766 |
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| Name | Class |
|---|---|
| The Danish Medical Research Council | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Fraction of inspired oxygen (FiO2) = 0.30 |
|
| B | Active Comparator | FiO2 = 0.80 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | During and 2 hours after surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Surgical wound infection | 14 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Atelectasis, pneumonia, respiratory insufficiency, second operation, mortality, length of postoperative hospitalization, admission to intensive care unit. | 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Sygehus | Aarhus | DK-8000 | Denmark | |||
| Copenhagen University Hospital, Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18945347 | Background | 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. | |
| 19826023 |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Copenhagen |
| DK-2100 |
| Denmark |
| Copenhagen University Hospital, Amager | Copenhagen | DK-2300 | Denmark |
| Copenhagen University Hospital, Bispebjerg | Copenhagen | DK-2400 | Denmark |
| Copenhagen University Hospital, Gentofte | Hellerup | DK-2900 | Denmark |
| Copenhagen University Hospital, Herlev | Herlev | DK-2730 | Denmark |
| Holbaek Hospital | Holbæk | DK-4300 | Denmark |
| Kolding Hospital | Kolding | DK-6000 | Denmark |
| Nykoebing Falster Hospital | Nykoebing Falster | DK-4800 | Denmark |
| Naestved Hospital | Næstved | DK-4700 | Denmark |
| Slagelse Hospital | Slagelse | DK-4200 | Denmark |
| Funen County Hospital | Svendborg | DK-5700 | Denmark |
| Vejle Hospital | Vejle | DK-7100 | Denmark |
| Viborg Hospital | Viborg | DK-8800 | Denmark |
| Result |
| 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. |