Trial Outcomes & Findings for Supplemental Oxygen Reduces Surgical Infection (NCT NCT00235456)

NCT ID: NCT00235456

Last Updated: 2017-02-10

Results Overview

Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 0 to 14 days after surgery
• Results posted on: 2017-02-10

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	150	150
Overall Study COMPLETED	148	143
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supplemental Oxygen Reduces Surgical Infection

Baseline characteristics by cohort

Measure	80% Perioperative Oxygen n=148 Participants 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.	30% Perioperative Oxygen n=143 Participants 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.	Total n=291 Participants Total of all reporting groups
Age, Continuous	64.2 years STANDARD_DEVIATION 11.8 • n=5 Participants	62.3 years STANDARD_DEVIATION 12.5 • n=7 Participants	63.3 years STANDARD_DEVIATION 12.2 • n=5 Participants
Gender Female	77 Participants n=5 Participants	52 Participants n=7 Participants	129 Participants n=5 Participants
Gender Male	71 Participants n=5 Participants	91 Participants n=7 Participants	162 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 14 days after surgery

Surgical wounds were defined as infected if they met Centers for Disease Control and Prevention definitions.

Outcome measures

Measure	80% Perioperative Oxygen n=148 Participants 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.	30% Perioperative Oxygen n=143 Participants 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.
Incisional Surgical Wound Infection	22 participants	35 participants

SECONDARY outcome

Timeframe: time to event after surgery to discharge from hospital

Time to return of bowel function, measured in days.

Outcome measures

Measure	80% Perioperative Oxygen n=148 Participants 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.	30% Perioperative Oxygen n=143 Participants 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.
Return of Bowel Function	3 days Standard Deviation 1.5	3.1 days Standard Deviation 1.7

SECONDARY outcome

Timeframe: time to event after surgery

time to return to ambulation after surgery, measured in days

Outcome measures

Measure	80% Perioperative Oxygen n=148 Participants 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.	30% Perioperative Oxygen n=143 Participants 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.
Return to Ambulation	3.9 days Standard Deviation 2.2	4.2 days Standard Deviation 2.6

SECONDARY outcome

Timeframe: time to event after surgery

Time to restarting feeding after surgery, measured in days.

Outcome measures

Measure	80% Perioperative Oxygen n=148 Participants 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.	30% Perioperative Oxygen n=143 Participants 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.
First Solid Food Intake	4.2 days Standard Deviation 2.2	4.4 days Standard Deviation 2.0

SECONDARY outcome

Timeframe: time to event after surgery

Time to staples removed, measured in days

Outcome measures

Measure	80% Perioperative Oxygen n=148 Participants 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.	30% Perioperative Oxygen n=143 Participants 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.
Staples Removed	10.5 days Standard Deviation 3.3	10.3 days Standard Deviation 3.0

SECONDARY outcome

Timeframe: time to hospital discharge after surgery

The number of days patient stayed in the hospital after surgery.

Outcome measures

Measure	80% Perioperative Oxygen n=148 Participants 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.	30% Perioperative Oxygen n=143 Participants 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.
Hospital Length of Stay	11.7 days Standard Deviation 7	10.5 days Standard Deviation 4.4

Adverse Events

80% Perioperative Oxygen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

30% Perioperative Oxygen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roberta Johnson

Cleveland Clinic

Phone: 216-444-9950

Email: johnsor13@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place