NCT02469311

Brief Summary

Subjects in the study were randomized to a treatment group using Chlorhexidine cloths or a standard-of-care group who only had a bath with antibacterial soap and water. Both groups received standard infection control practices during admission.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
539

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Status
terminated

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, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

2.1 years

First QC Date

June 9, 2015

Last Update Submit

March 13, 2018

Conditions

OsteoarthritisInfection

Keywords

infection; arthroplasty; chlorhexidine; hip; knee

Outcome Measures

Primary Outcomes (1)

  • The incidence of periprosthetic infection.

    One year

Study Arms (8)

Primary Control TKA

SHAM COMPARATOR

Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.

Other: Standard of care bathing with antibacterial soap and water

Primary Treatment TKA

ACTIVE COMPARATOR

Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.

Other: chlorhexidine impregnated cloths

Revision Treatment TKA

ACTIVE COMPARATOR

Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of a chlorhexidine impregnated cloths.

Other: chlorhexidine impregnated cloths

Revision Control TKA

SHAM COMPARATOR

Patients undergoing a second or revision total knee arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.

Other: Standard of care bathing with antibacterial soap and water

Primary Control THA

SHAM COMPARATOR

Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.

Other: Standard of care bathing with antibacterial soap and water

Primary Treatment THA

ACTIVE COMPARATOR

Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.

Other: chlorhexidine impregnated cloths

Revision Control THA

SHAM COMPARATOR

Patients undergoing a second or revision total hip arthroplasty will be randomized to the intervention of Standard of care bathing with antibacterial soap and water.

Other: Standard of care bathing with antibacterial soap and water

Revision Treatment THA

ACTIVE COMPARATOR

Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.

Other: chlorhexidine impregnated cloths

Interventions

chlorhexidine impregnated clothsOTHER

Pre-operative use of Chlorhexidine cloths night before and morning of surgery

Primary Treatment THAPrimary Treatment TKARevision Treatment THARevision Treatment TKA
Standard of care bathing with antibacterial soap and waterOTHER

Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery.

Primary Control THAPrimary Control TKARevision Control THARevision Control TKA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Joint replacement surgery for any reason
  • years or older

You may not qualify if:

  • unable to comply with study requirements
  • were pregnant
  • were under the age of 18 years
  • medical history of immunosuppression or systemic disease e.g. human immunodeficiency virus, status-post organ transplantation
  • received greater than 10 milligrams of prednisone equivalent for more than 10 days within 90 days prior to enrollment;
  • chronic hepatitis B or C infection
  • had an infection in or around the joint requiring surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoarthritisInfections

Interventions

Water

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Michael A Mont, MD

    Director, Rubin Instituted for Advanced Orthopedics and Joint Preservation and Replacement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 11, 2015

Study Start

March 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 14, 2018

Record last verified: 2018-03