Supplemental Oxygen and the Risk of Surgical Site Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2011-04-30

Brief Summary

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This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.

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Detailed Description

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This is a double-blinded prospective randomized,controlled trial to evaluate whether using a higher concentration of oxygen during and after surgery helps to decrease the wound infection rate in patients undergoing cesarean sections.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

80% oxygen during cesarean section

Group Type ACTIVE_COMPARATOR

Oxygen by mask

Intervention Type OTHER

Postoperatively, an aerosol face mask is used to deliver oxygen at 80%

2

30% oxygen during cesarean section

Group Type ACTIVE_COMPARATOR

Oxygen by mask

Intervention Type OTHER

Postoperatively, an aerosol face mask is used to deliver oxygen at 30%

Interventions

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Oxygen by mask

Postoperatively, an aerosol face mask is used to deliver oxygen at 80%

Intervention Type OTHER

Oxygen by mask

Postoperatively, an aerosol face mask is used to deliver oxygen at 30%

Intervention Type OTHER

Other Intervention Names

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Face mask delivery of supplemental oxygen at 80% face mask delivery of supplemental oxygen at 30%

Eligibility Criteria

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Inclusion Criteria

* mentally competent patients undergoing cesarean section under spinal or epidural anesthesia

Exclusion Criteria

* fever/chorioamnionitis; GBS positive on antibiotics; immunocompromised / HIV patients; on antibiotics for any reason; general anesthesia; age less than 18 years custody patients stat cesarean section

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes