NCT01340534

Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection

Supplemental Perioperative Oxygen at 80% FIO2 to Reduce the Incidence of Post-cesarean Wound Infection. A Randomised, Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Saint Thomas Hospital, Panama · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the use of supplemental oxygen at 80% FIO2 can reduce the incidence of surgical site infection after emergency cesarean section.

Detailed description

Surgical site infection (SSI) is one of the most important complications that can develop after a cesarean section. SSI can be mild or it can develop into septic shock and death, being cesarean section the most important cause of puerperal infections. Supplemental oxygen at high doses has been advocated as a protective factor for SSI. The purpose of this study is to determine if the use of oxygen at high doses (80% FIO2)can reduce the incidence of SSI after emergency cesarean section.

Conditions

• Surgical Wound Infection

Interventions

Type	Name	Description
DEVICE	Supplemental oxygen 80% FIO2	Use of oxygen 80% FIO2 during surgery and 2 hours after the procedure. For this purpose an oxygen mask with reservoir will be used (to guarantee the supply of 80% oxygen during and after surgery)
PROCEDURE	Use of air (no oxygen during surgery)	No use of oxygen during surgery or in the 2 hours after the procedure.

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-04-22
• Last updated: 2015-01-05

Locations

1 site across 1 country: Panama