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

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340534
• Other study ID #: MHST2011-02
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2011
• Last updated: January 1, 2015
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: January 2015
• Source: Saint Thomas Hospital, Panama
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• Supplemental 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)

Procedure:
• Use of air (no oxygen during surgery)
No use of oxygen during surgery or in the 2 hours after the procedure.

Locations

Country	Name	City	State
Panama	Saint Thomas Maternity Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

References & Publications (1)

Bleixen Admadé and Osvaldo Reyes, "Supplemental Perioperative Oxygen (80% FIO2) for the Prevention of Surgical Site Infection after Emergency Cesarean Section," ISRN Infectious Diseases, vol. 2013, Article ID 526163, 4 pages, 2013. doi:10.5402/2013/526163

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes