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Completed

NCT Number: NCT01340534

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

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.

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Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplemental oxygen 80% FIO2

Device

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 names: High dose oxygen

Use of air (no oxygen during surgery)

Procedure

No use of oxygen during surgery or in the 2 hours after the procedure.

Other names: No oxygen

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

Supplemental Perioperative Oxygen at 80% FIO2 to Reduce the Incidence of Post-cesarean Wound Infection. A Randomised, Clinical Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 22, 2011
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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