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

LifeBridge Health

Status and phase: Terminated; Phase 2

Conditions: Infection; Osteoarthritis

Treatments: Other: Standard of care bathing with antibacterial soap and water; Other: chlorhexidine impregnated cloths

Study type: Interventional

Funder types: Other

Identifiers

NCT02469311

LifeBridgeH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 539 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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539 participants in 8 patient groups

Primary Control TKA

Sham Comparator group

Description:

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.

Treatment:

Other: Standard of care bathing with antibacterial soap and water

Primary Treatment TKA

Active Comparator group

Description:

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

Treatment:

Other: chlorhexidine impregnated cloths

Revision Treatment TKA

Active Comparator group

Description:

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

Treatment:

Other: chlorhexidine impregnated cloths

Revision Control TKA

Sham Comparator group

Description:

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.

Treatment:

Other: Standard of care bathing with antibacterial soap and water

Primary Control THA

Sham Comparator group

Description:

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.

Treatment:

Other: Standard of care bathing with antibacterial soap and water

Primary Treatment THA

Active Comparator group

Description:

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

Treatment:

Other: chlorhexidine impregnated cloths

Revision Control THA

Sham Comparator group

Description:

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.

Treatment:

Other: Standard of care bathing with antibacterial soap and water

Revision Treatment THA

Active Comparator group

Description:

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

Treatment:

Other: chlorhexidine impregnated cloths