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

Saint Thomas Hospital (HST)

Status and phase: Completed; Phase 3

Conditions: Surgical Wound Infection

Treatments: Device: Supplemental oxygen 80% FIO2; Procedure: Use of air (no oxygen during surgery)

Study type: Interventional

Funder types: Other

Identifiers

NCT01340534

MHST2011-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 370 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age > 37 weeks
• Emergency cesarean section
• Regional Anesthesia

Exclusion criteria

• Elective cesarean section
• Fever of unknown origin at admission
• Twin pregnancy
• Chorioamnionitis
• Acute fetal distress that requires general anesthesia
• Immunocompromise
• Maternal Lung/Respiratory Disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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370 participants in 2 patient groups, including a placebo group

Oxygen 80% FIO2

Experimental group

Description:

Group of 181 patients that will receive supplemental oxygen 80% FIO2 during surgery (cesarean) and two hours after the procedure.

Treatment:

Device: Supplemental oxygen 80% FIO2

Use of air (no oxygen during surgery)

Placebo Comparator group

Description:

Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean).

Treatment:

Procedure: Use of air (no oxygen during surgery)