Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Phase 3
Locations
Panama
Study Type
Interventional
Intervention
Supplemental oxygen 80% FIO2
Use of air (no oxygen during surgery)
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection focused on measuring Surgical wound infection, Oxygen, Cesarean
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
Sites / Locations
- Saint Thomas Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxygen 80% FIO2
Use of air (no oxygen during surgery)
Arm Description
Group of 181 patients that will receive supplemental oxygen 80% FIO2 during surgery (cesarean) and two hours after the procedure.
Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01340534
First Posted
April 14, 2011
Last Updated
January 1, 2015
Sponsor
Saint Thomas Hospital, Panama
1. Study Identification
Unique Protocol Identification Number
NCT01340534
Brief Title
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection
Official Title
Supplemental Perioperative Oxygen at 80% FIO2 to Reduce the Incidence of Post-cesarean Wound Infection. A Randomised, Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Thomas Hospital, Panama
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Surgical wound infection, Oxygen, Cesarean
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
370 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen 80% FIO2
Arm Type
Experimental
Arm Description
Group of 181 patients that will receive supplemental oxygen 80% FIO2 during surgery (cesarean) and two hours after the procedure.
Arm Title
Use of air (no oxygen during surgery)
Arm Type
Placebo Comparator
Arm Description
Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean).
Intervention Type
Device
Intervention Name(s)
Supplemental oxygen 80% FIO2
Other Intervention Name(s)
High dose oxygen
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Use of air (no oxygen during surgery)
Other Intervention Name(s)
No oxygen
Intervention Description
No use of oxygen during surgery or in the 2 hours after the procedure.
Primary Outcome Measure Information:
Title
Number of participants with surgical site infection (SSI).
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Number of participants with respiratory complications trans or post surgery.
Description
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.
Time Frame
2 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bleixen Admadé, Resident
Organizational Affiliation
Saint Thomas Maternity Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osvaldo A Reyes, MD
Organizational Affiliation
Saint Thomas Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Thomas Maternity Hospital
City
Panama
Country
Panama
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
result
Learn more about this trial
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection
We'll reach out to this number within 24 hrs