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A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections

NCT ID: NCT00528008

Last Updated: 2012-11-09

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to find out if chlorhexidine gluconate solution is better at reducing the rate of wound infection after cesarean section compared to povidone-iodine.

Detailed Description

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Wound infection is a universal potential morbidity to any type of surgery. Over the years many studies have been completed to evaluate ways to decrease this morbidity. Recent literature has looked at different types of surgical solutions used in pre-operative cleansing. Chlorhexidine and povidone-iodine are two standard surgical prep solutions used on a global scale. The most recent literature has shown that chlorhexidine has a decreased wound infection rate for longer surgeries. Cesarean section, as a surgical time, varies from 20 - 60 minutes. There has been no known literature regarding wound infection rates using these two solutions in elective cesarean sections. This trial will review the rates of wound infection using chlorhexidine and povidone-iodine during elective cesarean section and determine if there is any statistically significant difference between the two solutions. The results could potentially decrease wound infection rates, decrease morbidity, decrease hospital length of stay, and help to guide further surgical management.

Conditions

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Wound Infection

Keywords

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infection sepsis povidone-iodine chlorhexidine gluconate fever erythema leukocytosis drainage vaginal discharge elective cesarean section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

povidone-iodine

Group Type ACTIVE_COMPARATOR

povidone-iodine solution

Intervention Type OTHER

Abdominal surgical field cleaned with 5% povidone-iodine detergent scrub, detergent cleaned from surgical area with sterile water, and then painted with 1% povidone-iodine solution.

B

chlorhexidine gluconate

Group Type ACTIVE_COMPARATOR

chlorhexidine gluconate

Intervention Type OTHER

Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.

Interventions

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povidone-iodine solution

Abdominal surgical field cleaned with 5% povidone-iodine detergent scrub, detergent cleaned from surgical area with sterile water, and then painted with 1% povidone-iodine solution.

Intervention Type OTHER

chlorhexidine gluconate

Abdominal surgical field painted once using 2% chlorhexidine in 70% alcohol.

Intervention Type OTHER

Other Intervention Names

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Betadine, Povidone, Minidyne Dexidine, Avagard, Bactoshield

Eligibility Criteria

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Inclusion Criteria

* Age \>19 years
* Gestational age \> 37 weeks
* Booked elective cesarean section

Exclusion Criteria

* Gestational age \< 37 weeks
* Premature rupture of membranes
* Onset of labor prior to procedure
* Evidence of maternal sepsis; maternal fever \> 38.5C
* LSCS for emergency issues: non-reassuring fetal status, placental abruption, failed induction
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eastern Health

OTHER

Sponsor Role collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula Mallaley, MD

Role: PRINCIPAL_INVESTIGATOR

Resident, Obstetrics and Gynecology, Memorial University of Newfoundland

Locations

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Women' s Health Centre, Eastern Health

St. John's, Newfoundland and Labrador, Canada

Site Status

Countries

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Canada

Other Identifiers

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HIC07.33

Identifier Type: -

Identifier Source: org_study_id