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

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ClinicalTrials.gov Identifier: NCT01340534
Recruitment Status : Completed
First Posted : April 22, 2011
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

April 14, 2011
April 22, 2011
January 5, 2015
October 2011
December 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01340534 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Surgical Wound Infection
  • 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
  • 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
  • Experimental: Oxygen 80% FIO2
    Group of 181 patients that will receive supplemental oxygen 80% FIO2 during surgery (cesarean) and two hours after the procedure.
    Intervention: Device: Supplemental oxygen 80% FIO2
  • Placebo Comparator: Use of air (no oxygen during surgery)
    Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean).
    Intervention: Procedure: Use of air (no oxygen during surgery)
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
362
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Panama
 
 
NCT01340534
MHST2011-02
No
Not Provided
Not Provided
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
Saint Thomas Hospital, Panama
Not Provided
Principal Investigator: Bleixen Admadé, Resident Saint Thomas Maternity Hospital
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Maternity Hospital
Saint Thomas Hospital, Panama
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP