Laparotomy Clinical Trial
Official title:
PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)
Verified date | October 2009 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1400 |
Est. completion date | November 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus Sygehus | Aarhus | |
Denmark | Copenhagen University Hospital, Amager | Copenhagen | |
Denmark | Copenhagen University Hospital, Bispebjerg | Copenhagen | |
Denmark | Copenhagen University Hospital, Rigshospitalet | Copenhagen | |
Denmark | Copenhagen University Hospital, Gentofte | Hellerup | |
Denmark | Copenhagen University Hospital, Herlev | Herlev | |
Denmark | Holbaek Hospital | Holbaek | |
Denmark | Kolding Hospital | Kolding | |
Denmark | Naestved Hospital | Naestved | |
Denmark | Nykoebing Falster Hospital | Nykoebing Falster | |
Denmark | Slagelse Hospital | Slagelse | |
Denmark | Funen County Hospital | Svendborg | |
Denmark | Vejle Hospital | Vejle | |
Denmark | Viborg Hospital | Viborg |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | The Danish Medical Research Council |
Denmark,
Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Høgdall 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, — View Citation
Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Simonsen I, Pulawska T, Walker LR, Skovgaard N, Heltø 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical wound infection | 14 days after surgery | No | |
Secondary | Atelectasis, pneumonia, respiratory insufficiency, second operation, mortality, length of postoperative hospitalization, admission to intensive care unit. | 30 days after surgery | Yes |
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