Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01340534|
Recruitment Status : Completed
First Posted : April 22, 2011
Last Update Posted : January 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Surgical Wound Infection||Device: Supplemental oxygen 80% FIO2 Procedure: Use of air (no oxygen during surgery)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Supplemental Perioperative Oxygen at 80% FIO2 to Reduce the Incidence of Post-cesarean Wound Infection. A Randomised, Clinical Trial|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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 Name: 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 Name: No oxygen
- 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.
- Number of participants with respiratory complications trans or post surgery. [ Time Frame: 2 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340534
|Saint Thomas Maternity Hospital|
|Principal Investigator:||Bleixen Admadé, Resident||Saint Thomas Maternity Hospital|
|Principal Investigator:||Osvaldo A Reyes, MD||Saint Thomas Maternity Hospital|