Trial Outcomes & Findings for Supplemental Postoperative Oxygen and Wound Infection in Morbidly Obese Patients (NCT NCT00315822)

Results Overview

Proportion of patients with the collapsed composite complications, including surgical wound infection, anastomotic leak, intra-abdominal abscess, peritonitis without leak, sepsis, wound dehiscence, intestinal obstruction, bleeding, and death during 60 days after surgery

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

400 participants

Primary outcome timeframe

60 days after surgery

Results posted on

2017-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	30% Oxygen Subjects undergoing surgery will receive routine administration of oxygen 30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen	80% Oxygen Subject undergoing surgery will receive supplemental oxygen 80% oxygen: Supplemental oxygen will be administered during surgery
Overall Study STARTED	198	202
Overall Study COMPLETED	198	202
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Supplemental Postoperative Oxygen and Wound Infection in Morbidly Obese Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	30% Oxygen n=198 Participants Subjects undergoing surgery will receive routine administration of oxygen 30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen	80% Oxygen n=202 Participants Subject undergoing surgery will receive supplemental oxygen 80% oxygen: Supplemental oxygen will be administered during surgery	Total n=400 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 12 • n=5 Participants	45 years STANDARD_DEVIATION 12 • n=7 Participants	44 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	162 Participants n=5 Participants	153 Participants n=7 Participants	315 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	49 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days after surgery

Proportion of patients with the collapsed composite complications, including surgical wound infection, anastomotic leak, intra-abdominal abscess, peritonitis without leak, sepsis, wound dehiscence, intestinal obstruction, bleeding, and death during 60 days after surgery

Outcome measures

Outcome measures
Measure	30% Oxygen n=198 Participants Subjects undergoing surgery will receive routine administration of oxygen 30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen	80% Oxygen n=202 Participants Subject undergoing surgery will receive supplemental oxygen 80% oxygen: Supplemental oxygen will be administered during surgery
Proportion of Patients With Collapsed Composite Complications	27 Participants	26 Participants

Adverse Events

30% Oxygen

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

80% Oxygen

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	30% Oxygen n=198 participants at risk Subjects undergoing surgery will receive routine administration of oxygen 30% oxygen: Subjects undergoing surgery will receive routine administration of oxygen	80% Oxygen n=202 participants at risk Subject undergoing surgery will receive supplemental oxygen 80% oxygen: Supplemental oxygen will be administered during surgery
Surgical and medical procedures All-cause mortality	1.0% 2/198 • Number of events 2 • within 60 days of surgery Death	0.50% 1/202 • Number of events 1 • within 60 days of surgery Death

Other adverse events

Adverse event data not reported

Additional Information

Daniel Sessler, MD

Cleveland Clinic

Phone: 216-444-4900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place