NCT01340534

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 5, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

April 14, 2011

Last Update Submit

January 1, 2015

Conditions

Surgical Wound Infection

Keywords

Surgical wound infectionOxygenCesarean

Outcome Measures

Primary Outcomes (1)

  • Number of participants with surgical site infection (SSI).

    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.

    2 months

Secondary Outcomes (1)

  • Number of participants with respiratory complications trans or post surgery.

    2 months

Study Arms (2)

Oxygen 80% FIO2

EXPERIMENTAL

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 air (no oxygen during surgery)

PLACEBO COMPARATOR

Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean).

Procedure: Use of air (no oxygen during surgery)

Interventions

Supplemental oxygen 80% FIO2DEVICE

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)

Also known as: High dose oxygen
Oxygen 80% FIO2
Use of air (no oxygen during surgery)PROCEDURE

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

Also known as: No oxygen
Use of air (no oxygen during surgery)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age \> 37 weeks
  • Emergency cesarean section
  • Regional Anesthesia

You may not qualify if:

  • Elective cesarean section
  • Fever of unknown origin at admission
  • Twin pregnancy
  • Chorioamnionitis
  • Acute fetal distress that requires general anesthesia
  • Immunocompromise
  • Maternal Lung/Respiratory Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Thomas Maternity Hospital

Panama City, Provincia de Panamá, Panama

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Bleixen Admadé, Resident

    Saint Thomas Maternity Hospital

    PRINCIPAL INVESTIGATOR

  • Osvaldo A Reyes, MD

    Saint Thomas Maternity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of Development and Research

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 22, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 5, 2015

Record last verified: 2015-01

Locations

PA(1)