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

Osteoarthritis Clinical Trial

— SAGE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02469311
• Other study ID #: LifeBridgeH
• Status: Terminated
• Phase: Phase 2
• First received: June 9, 2015
• Last updated: March 13, 2018
• Start date: March 2012
• Est. completion date: April 2014

Study information

• Verified date: March 2018
• Source: LifeBridge Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 539
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infection
• Osteoarthritis

Intervention

Other:
• chlorhexidine impregnated cloths
Pre-operative use of Chlorhexidine cloths night before and morning of surgery
• Standard of care bathing with antibacterial soap and water
Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LifeBridge Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of periprosthetic infection.		One year