NCT02469311

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

Prospective, Randomized Study Evaluating The Efficacy of Chlorhexidine Gluconate Impregnated No-Rinse Cloths in Reducing Surgical Site Infections for Total Hip and Knee Arthroplasty.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 539 (actual)
• Sponsor: LifeBridge Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	chlorhexidine impregnated cloths	Pre-operative use of Chlorhexidine cloths night before and morning of surgery
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2015-06-11
• Last updated: 2018-03-14