Surgical Wound Infection Clinical Trial
— Peri-OpOfficial title:
Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity
Previous studies have demonstrated that patients who undergo surgery while they under general anesthesia have fewer wound infections if they receive higher concentrations of oxygen but this has never been studied in women who are undergoing cesarean section. We plan to randomize women who are undergoing cesarean to receive either standard of care oxygen flow through a nasal cannula during their cesarean section only or a higher concentration of oxygen than they would typically receive through a face mask. Women will receive this therapy during their cesarean and for 2 hours afterwards. We will follow them after their surgery for evidence of infection either in their wound or their uterus.
Status | Completed |
Enrollment | 606 |
Est. completion date | May 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 12 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Pregnant patients undergoing a scheduled or unscheduled cesarean section with regional anesthesia Exclusion Criteria: - Urgent fetal or maternal indications for cesarean section precluding informed consent - Evidence of extrauterine infection - HIV infection - Chronic steroid or other immunosuppressant use - Patients undergoing general anesthesia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Barnes Jewish Hospital/Washington University School. of Medicine | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Barnes-Jewish Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of Wound Infection and Endometritis | 4 weeks post-cesarean | No | |
Secondary | Maternal temperature greater than 38 degrees after the first 24 hours post-op | 4 weeks | No | |
Secondary | Antibiotic usage greater than 24 hours post-op | 4 weeks | No | |
Secondary | Wound opening greater than one centimeter for any cause | 4 weeks | No | |
Secondary | Maternal hospital readmission | 4 weeks | No |
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