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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02469311

Acronym

SAGE

Enrollment

539

Registered

2015-06-11

Start date

2012-03-31

Completion date

2014-04-30

Last updated

2018-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Osteoarthritis

Keywords

infection; arthroplasty; chlorhexidine; hip; knee

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.

Interventions

OTHERchlorhexidine impregnated cloths

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

OTHERStandard of care bathing with antibacterial soap and water

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
The incidence of periprosthetic infection.	One year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026