N/A
Completed N=300
Supplemental Oxygen Reduces Surgical Infection
Source: ClinicalTrials.gov NCT00235456 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Incisional Surgical Wound Infection — 22; 35 participants — p=0.04
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incisional Surgical Wound Infection |
22; 35 | 0.04 sig |
| SECONDARY Return of Bowel Function |
3; 3.1 | 0.54 |
| SECONDARY Return to Ambulation |
3.9; 4.2 | 0.28 |
| SECONDARY First Solid Food Intake |
4.2; 4.4 | 0.57 |
| SECONDARY Staples Removed |
10.5; 10.3 | 0.71 |
| SECONDARY Hospital Length of Stay |
11.7; 10.5 | 0.09 |
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.
Data sourced from ClinicalTrials.gov (NCT00235456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.