NCT02202577

Brief Summary

Primary Hypothesis: chlorhexidine gluconate alcohol skin antiseptic preparation is superior to povidone-iodine scrub and paint skin antiseptic preparation for prevention of cesarean related surgical site infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
932

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

July 21, 2022

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

July 25, 2014

Results QC Date

January 13, 2022

Last Update Submit

July 18, 2022

Conditions

Surgical Site Infection

Keywords

Surgical site infectionSurgical site antisepsisCesarean Delivery

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Surgical Site Infection

    Number of Patients with Cesarean-Related surgical site infection by Center for Disease Control (CDC) criteria: superficial, deep, organ space.

    4 weeks after cesarean delivery

Secondary Outcomes (1)

  • Number of Patients With Non-infections Surgical Site Complications

    4 weeks after cesarean delivery

Study Arms (2)

Chlorhexidine - Isopropyl alcohol

EXPERIMENTAL

Pre-operative skin preparation with Chlorhexidine Gluconate- Isopropyl alcohol

Drug: Chlorhexidine - Isopropyl alcohol

Povidone-Iodine Scrub and Paint

EXPERIMENTAL

Pre-operative skin preparation with Povidone-Iodine Scrub and Paint

Drug: Povidone-Iodine Scrub and Paint

Interventions

Chlorhexidine - Isopropyl alcoholDRUG

Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA

Also known as: Chlora-Prep
Chlorhexidine - Isopropyl alcohol
Povidone-Iodine Scrub and PaintDRUG

Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA

Also known as: Betadine
Povidone-Iodine Scrub and Paint

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cesarean delivery
  • age 18-65
  • ability to consent in English or Spanish

You may not qualify if:

  • inability or unwillingness to consent to study participation in English or Spanish
  • current incarceration
  • pre-operative diagnosis of chorioamnionitis
  • perceived inability to complete follow up for data collection
  • any prior known allergy or adverse reaction to either study preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109-1998, United States

Location

Related Publications (3)

  • Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.

    PMID: 20054046BACKGROUND

  • 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

  • Springel EH, Wang XY, Sarfoh VM, Stetzer BP, Weight SA, Mercer BM. A randomized open-label controlled trial of chlorhexidine-alcohol vs povidone-iodine for cesarean antisepsis: the CAPICA trial. Am J Obstet Gynecol. 2017 Oct;217(4):463.e1-463.e8. doi: 10.1016/j.ajog.2017.05.060. Epub 2017 Jun 7.

    PMID: 28599898DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

EthanolPaintPovidone-Iodine

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsManufactured MaterialsTechnology, Industry, and AgricultureIodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental Materials

Limitations and Caveats

Lack of masking of clinical personnel to treatment assignment.

Results Point of Contact

Title
Edward H Springel, MD
Organization
Virginia Commonwealth University Health System
edward.springel@vcuhealth.org
804-828-8468

Study Officials

  • Brian B Mercer, MD

    MetroHealth Medical Center/Case Western Reserve

    PRINCIPAL INVESTIGATOR

  • Edward H Springel, MD

    MetroHealth Medical Center/Case Western Reserve

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 29, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 21, 2022

Results First Posted

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)