Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths.

NCT ID: NCT02469311

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 539 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-04-30

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.

Detailed Description

Between March 2012 and November 2012, patients scheduled for total hip arthroplasty (THA) or total knee arthroplasty (TKA) were randomized (539 patients; 554 arthroplasties) at the time of their preoperative clinic visit. Patients in the chlorhexidine protocol group (275 arthroplasties) applied 2% chlorhexidine gluconate-impregnated cloths to their skin the night before and the morning of surgical admission. Patients in the standard of care group (279 arthroplasties) took a bath with soap and water the night before surgical admission. Both groups were subject to standard infection control practices during admission. The primary outcome was periprosthetic infection incidence within one year of surgery, and secondary outcomes included the potential influence of risk factors for periprosthetic infection and incidence of adverse events.

Conditions

Osteoarthritis; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Primary Control TKA

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.

Group Type: SHAM_COMPARATOR

Standard of care bathing with antibacterial soap and water

Intervention Type: OTHER

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

Primary Treatment TKA

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

Group Type: ACTIVE_COMPARATOR

chlorhexidine impregnated cloths

Intervention Type: OTHER

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

Revision Treatment TKA

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

Group Type: ACTIVE_COMPARATOR

chlorhexidine impregnated cloths

Intervention Type: OTHER

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

Revision Control TKA

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.

Group Type: SHAM_COMPARATOR

Standard of care bathing with antibacterial soap and water

Intervention Type: OTHER

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

Primary Control THA

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.

Group Type: SHAM_COMPARATOR

Standard of care bathing with antibacterial soap and water

Intervention Type: OTHER

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

Primary Treatment THA

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

Group Type: ACTIVE_COMPARATOR

chlorhexidine impregnated cloths

Intervention Type: OTHER

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

Revision Control THA

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.

Group Type: SHAM_COMPARATOR

Standard of care bathing with antibacterial soap and water

Intervention Type: OTHER

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

Revision Treatment THA

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

Group Type: ACTIVE_COMPARATOR

chlorhexidine impregnated cloths

Intervention Type: OTHER

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

Interventions

chlorhexidine impregnated cloths

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

Intervention Type: OTHER

Standard of care bathing with antibacterial soap and water

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Joint replacement surgery for any reason
• 18 years or older

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LifeBridge Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A Mont, MD

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

LifeBridgeH

Identifier Type: -

Identifier Source: org_study_id