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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01340534
First received: April 14, 2011
Last updated: February 17, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Surgical Wound Infection
Device: Supplemental oxygen 80% FIO2
Procedure: Use of air (no oxygen during surgery)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Supplemental Perioperative Oxygen at 80% FIO2 to Reduce the Incidence of Post-cesarean Wound Infection. A Randomised, Clinical Trial

Resource links provided by NLM:


Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • Number of participants with surgical site infection (SSI). [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 370
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Air (no use of 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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340534

Locations
Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Principal Investigator: Bleixen Admadé, Resident Saint Thomas Maternity Hospital
Principal Investigator: Osvaldo A Reyes, MD Saint Thomas Maternity Hospital
  More Information

No publications provided

Responsible Party: Osvaldo A. Reyes T., Coordinator of Development and Research, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01340534     History of Changes
Other Study ID Numbers: MHST2011-02
Study First Received: April 14, 2011
Last Updated: February 17, 2013
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Surgical wound infection
Oxygen
Cesarean

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014