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

Saint Thomas Hospital, Panama370 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

370

Conditions

Surgical Wound Infection

Interventions

Supplemental oxygen 80% FIO2DEVICE

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)

Use of air (no oxygen during surgery)PROCEDURE

No use of oxygen during surgery or in the 2 hours after the procedure.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Outcomes

Primary Outcomes

Number of participants with surgical site infection (SSI).

The patients will be evaluated for evidence of surgical site infection before leaving the hospital, at 15 and 30 days post surgery. The presence of fever, supurative secretion through the wound or cutaneous changes compatible witn infection will be considered a surgical site infection (SSI). This outcome will be evaluated with a qualitative variable (presence of SSI). The patients will be clasiffied in accordance as "With SSI" or "Without SSI". This will allow us to determine if the use of oxygen at 80% FIO2 can reduce the incidence of SSI.

Time frame: 2 months

Secondary Outcomes

Number of participants with respiratory complications trans or post surgery.

Every patient will be evaluated during surgery and before leaving the hospital for signs of a respiratory complication (persistent cough, fever, dyspnea, atelectatic rales, wheezing). The presence of any of these signs will be used to classify the patients with a qualitative variable ("With Respiratory Complications" or "Without Respiratory Complications") and allow us to determine if the use of oxygen at 80% FIO2 is associated with more respiratory complications.

Time frame: 2 months

Data from ClinicalTrials.gov

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