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

Phase 3

Completed

• Conditions: Surgical Wound Infection
• Interventions: Procedure: Use of air (no oxygen during surgery); Device: Supplemental oxygen 80% FIO2

• Registration Number: NCT01340534
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief 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.

Study Timeline

• Study First Submitted: 2011-04-14
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-22
• Study Start: 2011-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-01
• Last Update Posted: 2015-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use of air (no oxygen during surgery)	Use of air (no oxygen during surgery)	Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean).
Oxygen 80% FIO2	Supplemental oxygen 80% FIO2	Group of 181 patients that will receive supplemental oxygen 80% FIO2 during surgery (cesarean) and two hours after the procedure.

Primary Outcome Measures

Name	Time	Method
Number of participants with surgical site infection (SSI).	2 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with respiratory complications trans or post surgery.	2 months	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.

Trial Locations

Locations (1)

Saint Thomas Maternity Hospital; 🇵🇦 Panama, Panama