A Comparison of Surgical Preparations and Wound Infection... | NCT00528008

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

NCT00528008

Sponsor

Memorial University of Newfoundland

Status

Terminated

Last Update Posted

Nov 9, 2012Estimated

Enrollment

268Actual

Phase

Phase 3

Conditions

Wound Infection

Interventions

povidone-iodine solution
chlorhexidine gluconate

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped following interim analysis.

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Sep 10, 2007

First Submission Date that Met QC Criteria

Sep 10, 2007

First Posted Date

Sep 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2012

Last Update Posted Date

Nov 9, 2012Estimated

Name	Class
Eastern Health	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

268Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	povidone-iodine	Other: povidone-iodine solution
B	Active Comparator	chlorhexidine gluconate	Other: chlorhexidine gluconate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
povidone-iodine solution	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to determine the rate of wound infection using two standard wound preparations: povidone-iodine and chlorhexidine gluconate		within 6 weeks following surgery

Secondary Outcomes

Measure	Description	Time Frame
readmission to hospital		within 6 weeks following surgery
extended length of admission		within 6 weeks following surgery
need for intravenous antibiotics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paula Mallaley, MD	Resident, Obstetrics and Gynecology, Memorial University of Newfoundland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women' s Health Centre, Eastern Health		St. John's	Newfoundland and Labrador	A1E 5K9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D018805	Sepsis
D005334	Fever
D004890	Erythema
D007964	Leukocytosis
D019522	Vaginal Discharge

Ancestor Terms

ID	Term
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011206	Povidone-Iodine
D011205	Povidone
C010882	chlorhexidine gluconate
D002710	Chlorhexidine

Ancestor Terms

ID	Term
D007466	Iodophors
D017613	Iodine Compounds
D007287	Inorganic Chemicals
D011145	Polyvinyls

Browse Leaves

Not provided

Browse Branches

Not provided