Supplemental Perioperative Oxygen at 80% FIO2 to Reduce the Incidence of Post-cesarean Wound Infection. A Randomised, Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Surgical Wound Infection
- Sponsor
- Saint Thomas Hospital, Panama
- Enrollment
- 370
- Locations
- 1
- Primary Endpoint
- Number of participants with surgical site infection (SSI).
- Status
- Completed
- Last Updated
- 11 years ago
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.
Investigators
Osvaldo A. Reyes T.
Coordinator of Development and Research
Saint Thomas Hospital, Panama
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
Outcomes
Primary Outcomes
Number of participants with surgical site infection (SSI).
Time Frame: 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 Outcomes
- Number of participants with respiratory complications trans or post surgery.(2 months)