NCT02027324

Brief Summary

There are approximately 1.4 million cesarean deliveries in the United States each year, and an average of 1250 elective cesarean deliveries each year at the Brigham and Women's Hospital (BWH) in Boston, Massachusetts. Among cesarean deliveries performed at BWH, approximately 2% of patients are diagnosed with a surgical site infection (SSI). Because SSI is associated with significant morbidity and increased cost of care, numerous guidelines exist to guide preoperative administration of prophylactic antibiotics. However, there are no recommendations for the choice of antiseptic solution for prevention of SSI. Among the currently popular antisepsis preparations, chlorhexidine-alcohol (CA) is known to decrease SSI in non-obstetric surgeries. However, the time required for CA to dry (\~ 3 min) to minimize flammability risk is disadvantageous in the setting of emergent cesarean delivery. Many institutions use povidone-iodine, another antisepsis preparation that does not require the mandatory drying time. Our randomized study aims to compare the incidence of SSI in patients receiving either CA or PI during elective cesarean delivery, and we hypothesize that CA would be associated with a lower incidence of SSI.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

1.7 years

First QC Date

January 2, 2014

Last Update Submit

January 11, 2016

Conditions

Surgical Site Infection

Keywords

Surgical site infectionCesarean deliveryAntisepsisPovidone iodineChlorhexidine alcoholEndometritis

Outcome Measures

Primary Outcomes (1)

  • Incidence of Surgical Site Infection within 30 days of Cesarean Delivery

    At 3 years after first patient enrollment

Secondary Outcomes (2)

  • Type of SSI (based on CDC classification)

    3 years after initial enrollment

  • Time to diagnosis of SSI

    3 years after initial enrollment

Study Arms (2)

Chlorhexidine-alcohol group

EXPERIMENTAL

2% chlorhexidine in 70% isopropyl alcohol in accordance with manufacturer's instructions for safe usage.

Drug: Chlorhexidine-alcohol group

Povidone-Iodine group

EXPERIMENTAL

10% Povidone-iodine applied topically according to manufacturer's instructions

Drug: Povidone-Iodine Group

Interventions

Chlorhexidine-alcohol groupDRUG

2% chlorhexidine in 70% isopropyl alcohol in accordance with manufacturer's instructions for safe usage.

Also known as: Chloraprep
Chlorhexidine-alcohol group
Povidone-Iodine GroupDRUG

10% Povidone-Iodine for surgical antisepsis according to manufacturer's instructions.

Also known as: Betadine
Povidone-Iodine group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients scheduled for elective cesarean delivery

You may not qualify if:

  • Allergy to either of the antiseptic preparations
  • Ongoing active skin or systemic infection
  • Pre-operative antibiotic therapy for non-surgical reasons
  • Those unable to receive antibiotic prophylaxis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Surgical Wound InfectionEndometritis

Interventions

ChlorhexidineEthanolPopulation GroupsPovidone-Iodine

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsAlcoholsDemographyPopulation CharacteristicsIodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Arvind Palanisamy, MD, FRCA

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anaesthesia

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 6, 2014

Study Start

June 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

US(1)