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

Study Overview
=================
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.

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

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Device: Supplemental oxygen 80% FIO2
* Procedure: Use of air (no oxygen during surgery)


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen 80% FIO2<br>Group of 181 patients that will receive supplemental oxygen 80% FIO2 during surgery (cesarean) and two hours after the procedure. | Device: Supplemental oxygen 80% FIO2<br>* 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)<br>* Other names: High dose oxygen;|
| Placebo Comparator: Use of air (no oxygen during surgery)<br>Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean). | Procedure: Use of air (no oxygen during surgery)<br>* No use of oxygen during surgery or in the 2 hours after the procedure.<br>* Other names: No oxygen;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical wound infection, Oxygen, Cesarean