NCT01472549

Brief Summary

The investigators propose a randomized controlled clinical trial to determine the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infections at cesarean section. While estimates vary, surgical site infections complicate up to 5 - 10% of all cesarean sections and result in significant human suffering and excess health care costs. Interventions such as preoperative antibiotic prophylaxis reduce surgical site infections by 60%, but the rate of infection remains high. There is therefore a great need to identify and test other potential interventions to further reduce these infections. The skin is a major source of pathogens that cause surgical site infection. Therefore, optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical site infections. There is paucity of evidence to guide the choice of antiseptic for skin preparation at cesarean section. To date, only two underpowered trials have been published comparing two methods of preoperative skin preparation at cesarean section. A recent randomized trial in adults undergoing clean-contaminated mostly general surgical procedures demonstrated a 41% reduction in surgical site infection with the use of chlorhexidine-alcohol when compared to the more commonly used povidone-iodine. While it is plausible that findings from trials in other clean-contaminated surgical procedures may apply to cesarean sections, physiological changes in pregnancy, the peculiar dual microbial source for cesarean-related infections and the hormone-mediated immune-modulation in pregnancy make the validity of such extrapolation uncertain. The study has the following specific aims: Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces surgical site infections compared to iodine-alcohol. Secondary Aim 1: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces bacterial contamination at the surgical site compared to iodine-alcohol. Secondary Aim 2: To determine clinical outcomes and medical costs associated with cesarean-related infections and quantify potential cost savings attributable to use of chlorhexidine-alcohol for preoperative skin preparation at cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 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

September 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

August 8, 2018

Completed
Last Updated

August 8, 2018

Status Verified

July 1, 2018

Enrollment Period

3.8 years

First QC Date

September 20, 2011

Results QC Date

April 3, 2018

Last Update Submit

July 12, 2018

Conditions

Surgical Site Infections

Keywords

PreoperativeAntisepticsComparativeCostEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Surgical Site Infection

    Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.

    30 days

Secondary Outcomes (7)

  • Length of Hospital Stay

    30 days

  • Number of Participants With Re-admissions or Office Visits for Wound-related Problems

    30 days

  • Number of Participants With Endometritis

    30 days

  • Number of Participants With Skin Irritation

    30 days

  • Number of Participants With Allergic Reaction

    30 days

  • +2 more secondary outcomes

Study Arms (2)

Iodine-alcohol

ACTIVE COMPARATOR

8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health)

Drug: Iodine-alcohol

Chlorhexidine-alcohol

EXPERIMENTAL

2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health)

Drug: Chlorhexidine-alcohol

Interventions

Iodine-alcoholDRUG

Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.

Also known as: Prevail-FX, Cardinal Health
Iodine-alcohol
Chlorhexidine-alcoholDRUG

Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation

Also known as: ChloraPrep, Cardinal Health
Chlorhexidine-alcohol

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women undergoing cesarean delivery at Barnes-Jewish Hospital.

You may not qualify if:

  • Inability to obtain consent; allergy to chlorhexidine, alcohol, iodine, shellfish; and evidence of infection adjacent to operative site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63108, United States

Location

Related Publications (2)

  • Tuuli MG, Liu J, Stout MJ, Martin S, Cahill AG, Odibo AO, Colditz GA, Macones GA. A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery. N Engl J Med. 2016 Feb 18;374(7):647-55. doi: 10.1056/NEJMoa1511048. Epub 2016 Feb 4.

    PMID: 26844840RESULT

  • 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

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

IodineEthanolChlorhexidine

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HalogensElementsInorganic ChemicalsAlcoholsOrganic ChemicalsBiguanidesGuanidinesAmidines

Results Point of Contact

Title
Methodius Tuuli
Organization
Washington University
methodiustuuli@yahoo.com
6785582874

Study Officials

  • Methodius G Tuuli, MD, MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • George Macones, MD, MSCE

    Washington University School of Medicine

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

September 20, 2011

First Posted

November 16, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 8, 2018

Results First Posted

August 8, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)