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

Primary Purpose

Wound Infection

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

povidone-iodine solution

chlorhexidine gluconate

About this trial

This is an interventional treatment trial for Wound Infection focused on measuring infection, sepsis, povidone-iodine, chlorhexidine gluconate, fever, erythema, leukocytosis, drainage, vaginal discharge, elective cesarean section

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Women' s Health Centre, Eastern Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

povidone-iodine

chlorhexidine gluconate

Outcomes

Primary Outcome Measures

to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate

Secondary Outcome Measures

readmission to hospital

extended length of admission

need for intravenous antibiotics

need for repeat procedure such as drainage

increased outpatient surveillance

Full Information

NCT ID

NCT00528008

First Posted

September 10, 2007

Last Updated

November 8, 2012

Sponsor

Memorial University of Newfoundland

Collaborators

Eastern Health

1. Study Identification

Unique Protocol Identification Number

NCT00528008

Brief Title

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

Official Title

Povidone-iodine vs. Chlorhexidine Gluconate - A Comparison of Surgical Preparations and Wound Infection Rates for Elective Cesarean Sections

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Why Stopped

Study was stopped following interim analysis.

Study Start Date

December 2007 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial University of Newfoundland

Collaborators

Eastern Health

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Infection

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

268 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

povidone-iodine

Arm Title

Arm Type

Active Comparator

Arm Description

chlorhexidine gluconate

Intervention Type

Other

Intervention Name(s)

povidone-iodine solution

Other Intervention Name(s)

Betadine, Povidone, Minidyne

Intervention Description

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

Intervention Name(s)

chlorhexidine gluconate

Other Intervention Name(s)

Dexidine, Avagard, Bactoshield

Intervention Description

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

Primary Outcome Measure Information:

Title

to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate

Time Frame