Wound Infection
Conditions
Keywords
oxygen, surgical complications, colo-rectal resections
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.
Interventions
PROCEDUREPerioperative 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.
PROCEDUREStandard 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.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Surgical Wound Infection | 0 to 14 days after surgery | Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Return of Bowel Function | time to event after surgery to discharge from hospital | Time to return of bowel function, measured in days. |
| Return to Ambulation | time to event after surgery | time to return to ambulation after surgery, measured in days |
| First Solid Food Intake | time to event after surgery | Time to restarting feeding after surgery, measured in days. |
| Staples Removed | time to event after surgery | Time to staples removed, measured in days |
| Hospital Length of Stay | time to hospital discharge after surgery | The number of days patient stayed in the hospital after surgery. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 148 |
| 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. | 143 |
| Total | 291 |
Baseline characteristics
| Characteristic | 80% Perioperative Oxygen | 30% Perioperative Oxygen | Total |
|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 11.8 | 62.3 years STANDARD_DEVIATION 12.5 | 63.3 years STANDARD_DEVIATION 12.2 |
| Gender Female | 77 Participants | 52 Participants | 129 Participants |
| Gender Male | 71 Participants | 91 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 148 | 0 / 143 |
| serious Total, serious adverse events | 0 / 148 | 0 / 143 |
Outcome results
Primary
Incisional Surgical Wound Infection
Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.
Time frame: 0 to 14 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 80% Perioperative Oxygen | Incisional Surgical Wound Infection | 22 participants |
| 30% Perioperative Oxygen | Incisional Surgical Wound Infection | 35 participants |
p-value: 0.0495% CI: [0.38, 0.98]Chi-squared
Secondary
First Solid Food Intake
Time to restarting feeding after surgery, measured in days.
Time frame: time to event after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 80% Perioperative Oxygen | First Solid Food Intake | 4.2 days | Standard Deviation 2.2 |
| 30% Perioperative Oxygen | First Solid Food Intake | 4.4 days | Standard Deviation 2 |
p-value: 0.57t-test, 2 sided
Secondary
Hospital Length of Stay
The number of days patient stayed in the hospital after surgery.
Time frame: time to hospital discharge after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 80% Perioperative Oxygen | Hospital Length of Stay | 11.7 days | Standard Deviation 7 |
| 30% Perioperative Oxygen | Hospital Length of Stay | 10.5 days | Standard Deviation 4.4 |
p-value: 0.09t-test, 2 sided
Secondary
Return of Bowel Function
Time to return of bowel function, measured in days.
Time frame: time to event after surgery to discharge from hospital
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 80% Perioperative Oxygen | Return of Bowel Function | 3 days | Standard Deviation 1.5 |
| 30% Perioperative Oxygen | Return of Bowel Function | 3.1 days | Standard Deviation 1.7 |
p-value: 0.54t-test, 2 sided
Secondary
Return to Ambulation
time to return to ambulation after surgery, measured in days
Time frame: time to event after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 80% Perioperative Oxygen | Return to Ambulation | 3.9 days | Standard Deviation 2.2 |
| 30% Perioperative Oxygen | Return to Ambulation | 4.2 days | Standard Deviation 2.6 |
p-value: 0.28t-test, 2 sided
Secondary
Staples Removed
Time to staples removed, measured in days
Time frame: time to event after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 80% Perioperative Oxygen | Staples Removed | 10.5 days | Standard Deviation 3.3 |
| 30% Perioperative Oxygen | Staples Removed | 10.3 days | Standard Deviation 3 |
p-value: 0.71t-test, 2 sided