NCT01870583

Brief Summary

In women that undergo non-emergency cesarean delivery, we are comparing the skin preparation solutions for best outcome of surgical site infection. The three different solutions are: Group 1: Iodine povidone based skin preparation solution. Group 2: Chlorhexidine based skin preparation solution or Group 3: Combination usage of iodine povidone and chlorhexidine based skin preparation solutions. Women are prospectively randomized to one of the three groups and followed until thier postpartum visit at 6-8 weeks following delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,404

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

June 19, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

June 3, 2013

Results QC Date

May 19, 2017

Last Update Submit

September 2, 2017

Conditions

Surgical Site Infection Following Cesarean Delivery

Keywords

Cesarean deliverySurgical site infectionPregnancyPostpartum

Outcome Measures

Primary Outcomes (1)

  • Cesarean Surgical Site Infection

    Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.

    42 days after delivery

Study Arms (3)

Combination iodine and chlorhexidine

ACTIVE COMPARATOR

The combincation skin preparation will utilize the iodine based preparation first followed by the chlorhexidine based skin preparation prior to cesarean delivery.

Drug: Combination iodine and chlorhexidine

Chlorhexidine

ACTIVE COMPARATOR

Chlorhexidine based skin preparation solution applied to skin prior to cesarean delivery

Drug: Chlorhexidine

Iodine povidone

ACTIVE COMPARATOR

Iodine povidone based skin preparation solution applied to skin prior to cesarean delivery

Drug: Iodine povidone

Interventions

Iodine povidoneDRUG

Iodine skin preparation solution prior to cesarean delivery

Iodine povidone
ChlorhexidineDRUG

Chlorhexidine skin preparation solution prior to cesarean delivery

Chlorhexidine
Combination iodine and chlorhexidineDRUG

Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery

Combination iodine and chlorhexidine

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age \> 37 weeks 0/7 days
  • Non-emergency indication for cesarean

You may not qualify if:

  • Urogenital tract infection within 2 weeks prior to surgery
  • Chronic oral or injectable steroid use (\> 2 weeks)
  • Emergency cesarean delivery
  • Participation in another research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montefiore Medical Center Weiler Division

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center Wakefield Division

The Bronx, New York, 10466, United States

Location

Related Publications (11)

  • Zinn J, Jenkins JB, Harrelson B, Wrenn C, Haynes E, Small N. Differences in intraoperative prep solutions: a retrospective chart review. AORN J. 2013 May;97(5):552-8. doi: 10.1016/j.aorn.2013.03.006.

    PMID: 23622828BACKGROUND

  • Berkelman RL, Holland BW, Anderson RL. Increased bactericidal activity of dilute preparations of povidone-iodine solutions. J Clin Microbiol. 1982 Apr;15(4):635-9. doi: 10.1128/jcm.15.4.635-639.1982.

    PMID: 7040461BACKGROUND

  • Stinner DJ, Krueger CA, Masini BD, Wenke JC. Time-dependent effect of chlorhexidine surgical prep. J Hosp Infect. 2011 Dec;79(4):313-6. doi: 10.1016/j.jhin.2011.08.016. Epub 2011 Oct 15.

    PMID: 22000737BACKGROUND

  • Olsen MA, Butler AM, Willers DM, Gross GA, Hamilton BH, Fraser VJ. Attributable costs of surgical site infection and endometritis after low transverse cesarean delivery. Infect Control Hosp Epidemiol. 2010 Mar;31(3):276-82. doi: 10.1086/650755.

    PMID: 20102279BACKGROUND

  • Gong SP, Guo HX, Zhou HZ, Chen L, Yu YH. Morbidity and risk factors for surgical site infection following cesarean section in Guangdong Province, China. J Obstet Gynaecol Res. 2012 Mar;38(3):509-15. doi: 10.1111/j.1447-0756.2011.01746.x. Epub 2012 Feb 22.

    PMID: 22353388BACKGROUND

  • Miner AL, Sands KE, Yokoe DS, Freedman J, Thompson K, Livingston JM, Platt R. Enhanced identification of postoperative infections among outpatients. Emerg Infect Dis. 2004 Nov;10(11):1931-7. doi: 10.3201/eid1011.040784.

    PMID: 15550202BACKGROUND

  • Opoien HK, Valbo A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. doi: 10.1080/00016340701515225.

    PMID: 17712651BACKGROUND

  • Lobdell KW, Stamou S, Sanchez JA. Hospital-acquired infections. Surg Clin North Am. 2012 Feb;92(1):65-77. doi: 10.1016/j.suc.2011.11.003. Epub 2011 Dec 5.

    PMID: 22269261BACKGROUND

  • Segal CG, Anderson JJ. Preoperative skin preparation of cardiac patients. AORN J. 2002 Nov;76(5):821-8. doi: 10.1016/s0001-2092(06)61035-1.

    PMID: 12463081BACKGROUND

  • Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5.

    PMID: 32580252DERIVED

  • Ngai IM, Van Arsdale A, Govindappagari S, Judge NE, Neto NK, Bernstein J, Bernstein PS, Garry DJ. Skin Preparation for Prevention of Surgical Site Infection After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2015 Dec;126(6):1251-1257. doi: 10.1097/AOG.0000000000001118.

    PMID: 26551196DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-IodineChlorhexidine

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureBiguanidesGuanidinesAmidines

Results Point of Contact

Title
Dr David Garry
Organization
Stony Brook Medicine
david.garry@stonybrookmedicine.edu
631-444-7650

Study Officials

  • David A Wallach, CIP

    Einstein IRB

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Co-Director Obstetrics & MFM service Wakefield Division

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 2, 2017

Results First Posted

June 19, 2017

Record last verified: 2017-09

Locations

US(2)