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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00364741
Other study ID # 2006-001710-32
Secondary ID GCP-2006-101KF 0
Status Completed
Phase Phase 4
First received August 15, 2006
Last updated October 15, 2009
Start date October 2006
Est. completion date November 2008

Study information

Verified date October 2009
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Oxygen
During and 2 hours after surgery

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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

Outcome

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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