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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01340534

Enrollment

370

Registered

2011-04-22

Start date

2011-10-31

Completion date

2011-12-31

Last updated

2015-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Infection

Keywords

Surgical wound infection, Oxygen, Cesarean

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.

Interventions

DEVICESupplemental 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)

PROCEDUREUse of air (no oxygen during surgery)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026