Clinical trial NCT00235456: Supplemental Oxygen Reduces Surgical Infection
Official title: Supplemental Perioperative Oxygen Reduces the Risk of Surgical Wound Infection: A Randomized, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection
Keywords: oxygen
surgical complications
colo-rectal resections
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2005-10-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Supplemental perioperative oxygen has been reported to halve or double the risk of surgical wound infection. We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery. Colorectal surgery patients (n=300) were randomly assigned to 30% or 80% FiO2 intraoperatively and 6 hours postoperatively. Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. Wound infection rates were compared with chi-square analysis. Logistic regression identified the contribution of potential confounding factors. Surgical wound infection occurred in 24.4% of patients receiving 30% oxygen, but only 14.9% of those receiving 80% oxygen (P\<0.039). According to logistic regression, the relative risk of infection in patients given supplemental oxygen was 0.46 (P=0.035). Supplemental inspired oxygen reduced wound infection risk by roughly a factor of two. We thus recommend that supplemental oxygen be provided to patients undergoing colorectal surgery.

Detailed description: Context: Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection.

Objective: We tested the hypothesis that supplemental oxygen reduces infection risk following colorectal surgery.

Design: Randomized, controlled trial. Setting: Fourteen Spanish hospitals. Patients: Three hundred patients undergoing elective colorectal surgery. Interventions: Patients were randomly assigned to either 30% or 80% FiO2 intraoperatively and for 6 hours after surgery. Anesthetic management and antibiotic administration were standardized.

Main outcome measures: Wound infections were diagnosed by blinded investigators using Centers for Disease Control criteria. Baseline patient characteristics, anesthetic management, and potential confounding factors were recorded. The wound infection rate in the 30% and 80% oxygen groups was compared with chi-square analysis. A logistic regression was used to identify the contribution of potential confounding factors.

Eligibility criteria: Inclusion Criteria:

* Elective colorectal resection,
* Patients having abdominal-peritoneal reconstructions were included, but not those scheduled for minor colon surgery (e.g., polypectomy, isolated colostomy) or laparoscopic surgery.

Exclusion Criteria:

* Exclusion criteria included expected surgery time of less than one hour, fever or existing signs of infection, diabetes mellitus (type I or II), HIV infection, weight loss exceeding 20% in the previous three months, serum albumin concentration \< 30 g/L, and a leukocyte count \<2500 cells/ml.

Primary outcomes:
measure: Incisional Surgical Wound Infection
timeFrame: 0 to 14 days after surgery
Secondary outcomes:
measure: Return of Bowel Function
timeFrame: time to event after surgery to discharge from hospital
measure: Return to Ambulation
timeFrame: time to event after surgery
measure: First Solid Food Intake
timeFrame: time to event after surgery
measure: Staples Removed
timeFrame: time to event after surgery
measure: Hospital Length of Stay
timeFrame: time to hospital discharge after surgery
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario
Study officials:
affiliation: Hospital Clínico Universitario de Valencia
name: F. Javier Belda, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Belda FJ, Aguilera L, Garcia de la Asuncion J, Alberti J, Vicente R, Ferrandiz L, Rodriguez R, Company R, Sessler DI, Aguilar G, Botello SG, Orti R; Spanish Reduccion de la Tasa de Infeccion Quirurgica Group. Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial. JAMA. 2005 Oct 26;294(16):2035-42. doi: 10.1001/jama.294.16.2035.