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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Device: Supplemental oxygen 80% FIO2; Procedure: Use of air (no oxygen during surgery)

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 Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 3

Contacts and Locations

Study Locations

• Panama
  • Panama, Panama
    • Saint Thomas Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxygen 80% FIO2; 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; 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); Other Names: High dose oxygen
Placebo Comparator: Use of air (no oxygen during surgery); Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean).	Procedure: Use of air (no oxygen during surgery); No use of oxygen during surgery or in the 2 hours after the procedure.; 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

Collaborators and Investigators

• Sponsor: Saint Thomas Hospital, Panama
• Investigators: Principal Investigator: Bleixen Admadé, Resident, Saint Thomas Maternity Hospital; Principal Investigator: Osvaldo A Reyes, MD, Saint Thomas Maternity Hospital

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: April 20, 2011
• First Posted (Estimate): April 22, 2011

Study Record Updates

• Last Update Posted (Estimate): January 5, 2015
• Last Update Submitted That Met QC Criteria: January 1, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: Cesarean; Oxygen; Surgical wound infection
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: MHST2011-02