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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80% perioperative oxygen | Active Comparator | Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
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| 30% perioperative oxygen | Placebo Comparator | Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perioperative supplemental oxygen | Procedure | Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional Surgical Wound Infection | Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions. | 0 to 14 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Return of Bowel Function | Time to return of bowel function, measured in days. | time to event after surgery to discharge from hospital |
| Return to Ambulation | time to return to ambulation after surgery, measured in days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| F. Javier Belda, MD, PhD | Hospital Clínico Universitario de Valencia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario | Valencia | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16249417 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 80% Perioperative Oxygen | Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
| FG001 | 30% Perioperative Oxygen | Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 80% Perioperative Oxygen | Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incisional Surgical Wound Infection | Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions. | Posted | Number | participants | 0 to 14 days after surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 80% Perioperative Oxygen | Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta Johnson | Cleveland Clinic | 216-444-9950 | johnsor13@ccf.org |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Standard oxygen | Procedure | Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
|
| time to event after surgery |
| First Solid Food Intake | Time to restarting feeding after surgery, measured in days. | time to event after surgery |
| Staples Removed | Time to staples removed, measured in days | time to event after surgery |
| Hospital Length of Stay | The number of days patient stayed in the hospital after surgery. | time to hospital discharge after surgery |
| BG001 | 30% Perioperative Oxygen | Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Gender | Count of Participants | Participants |
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Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.
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| Secondary | Return of Bowel Function | Time to return of bowel function, measured in days. | Posted | Mean | Standard Deviation | days | time to event after surgery to discharge from hospital |
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| Secondary | Return to Ambulation | time to return to ambulation after surgery, measured in days | Posted | Mean | Standard Deviation | days | time to event after surgery |
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| Secondary | First Solid Food Intake | Time to restarting feeding after surgery, measured in days. | Posted | Mean | Standard Deviation | days | time to event after surgery |
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| Secondary | Staples Removed | Time to staples removed, measured in days | Posted | Mean | Standard Deviation | days | time to event after surgery |
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| Secondary | Hospital Length of Stay | The number of days patient stayed in the hospital after surgery. | Posted | Mean | Standard Deviation | days | time to hospital discharge after surgery |
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| 0 |
| 148 |
| 0 |
| 148 |
| EG001 | 30% Perioperative Oxygen | Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. | 0 | 143 | 0 | 143 |
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