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

Phase 2

Terminated

• Conditions: Infection; Osteoarthritis
• Interventions: Other: Standard of care bathing with antibacterial soap and water; Other: chlorhexidine impregnated cloths

• Registration Number: NCT02469311
• Lead Sponsor: LifeBridge Health

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 539

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Revision Control THA	Standard of care bathing with antibacterial soap and water	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.
Revision Treatment THA	chlorhexidine impregnated cloths	Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
Primary Treatment TKA	chlorhexidine impregnated cloths	Patients undergoing a first or primary total knee arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
Revision Control TKA	Standard of care bathing with antibacterial soap and water	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.
Primary Control THA	Standard of care bathing with antibacterial soap and water	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.
Primary Control TKA	Standard of care bathing with antibacterial soap and water	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.
Primary Treatment THA	chlorhexidine impregnated cloths	Patients undergoing a first or primary total hip arthroplasty will be randomized to the intervention of chlorhexidine impregnated cloths.
Revision Treatment TKA	chlorhexidine impregnated cloths	Patients undergoing a second or subsequent or a revision total knee arthroplasty will be randomized to the intervention of a chlorhexidine impregnated cloths.

Primary Outcome Measures

Name	Time	Method
The incidence of periprosthetic infection.	One year