Recruiting

Antiseptic Preparation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05828810

Conditions

Revision Total Hip Arthroplasty (RTHA)

Revision Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chlorhexidne Gluconate-Alcohol Skin Preparation

Poviodine-iodine Skin Preparation

Study Details

Brief summary:

The goal of this clinical trial is to compare two types of skin preparation solutions (chlorhexidine gluconate-alcohol solution and povidone-iodine solution) that help eliminate harmful bacteria on the skin at the time of surgery for patients having revision arthroplasty surgery of the hip or knee.

The main outcome of interest for the definitive study is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery.

For the pilot trial, our main interest is to determine feasibility of a definitive trial. Feasibility outcomes will include: ability to recruit patients, ability to randomize patients, ability to collect complete data, estimate the event rate of our primary outcome, ability to carry out data linkages and determine the accuracy of collected data.

Participants will be contacted at two time points after surgery to complete a 5-minute survey: after 30 days, and after 1 year.

Conditions

Revision Total Hip Arthroplasty (RTHA)

Revision Total Knee Arthroplasty

Study ID

NCT05828810

Start date

Jul 25, 2023

Status verified date

Mar, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 18 years or older
2. Scheduled to undergo aseptic revision total hip arthroplasty or total knee arthroplasty with exchange of at least one prosthetic component

Exclusion Criteria:

1. Revision for prosthetic joint infection or wound complication
2. Known history of previous prosthetic joint infection in the operative joint
3. Any degree of clinical concern for prosthetic joint infection
4. History of allergy to iodine, chlorhexidine, or alcohol

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Chlorhexidine gluconate-alcohol solution

Chlorhexidine gluconate-alcohol solution is a type of solution that has antiseptic properties, which means it helps to eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection.

active comparator: Povidone-iodine solution

Povidone-iodine solution is a type of solution that has antiseptic properties, which means it helps to eliminate harmful bacteria on the skin at the time of surgery, and therefore, reduce the risk of infection.

Interventions

Chlorhexidne Gluconate-Alcohol Skin Preparation

Participants will undergo skin antisepsis with 4% chlorhexidine gluconate pre-wash, followed by 2% chlorhexidine gluconate with 70% isopropyl alcohol skin preparation.

The surgical field to be sterilized will be at the discretion of the surgical team, but typically includes the distal torso to ankle for patients undergoing hip arthroplasty and proximal thigh to ankle for patients undergoing knee arthroplasty.

Pre-wash of the surgical area will be carried out using a wet chlorhexidine surgical scrub brush followed by immediate drying using towels. The definitive preparation will then be carried out using tinted chlorhexidine gluconate-alcohol sponges applied with forceps. The drying time and the minimum number of sponge packs used will comply with the product 'Instructions for Use'. The drapes can be applied as per the surgeon's usual approach and they will be treated according to the institution and surgeon's routine practice for draping and surgical site infection prevention.

Poviodine-iodine Skin Preparation

Participants will undergo skin antisepsis with 7.5% povidone-iodine detergent pre-wash, followed by 10% povidone-iodine skin preparation.

The surgical field to be sterilized will be at the discretion of the surgical team, but typically includes the distal torso to ankle for patients undergoing hip arthroplasty and proximal thigh to ankle for patients undergoing knee arthroplasty.

Pre-wash of the surgical area will be carried out using iodine detergent soaked gauze pads followed by immediate drying using towels. The definitive preparation will then be carried out using povidone-iodine soaked gauze pads applied with forceps. The drapes can be applied as per the surgical team's usual approach and they otherwise will be treated according to the institution and surgeon's routine practice for draping and surgical site infection prevention.

Primary outcome measure

  • Assessment of accrual [ Time Frame: 2 years ]
  • Ability to deliver intervention the patient is randomized to receive [ Time Frame: 2 years ]
  • Ability to collect complete data from participants [ Time Frame: 2 years ]
  • To estimate the aggregate incidence of reoperation for wound complication or PJI at one year [ Time Frame: 2 years ]
  • Ability to link collected outcome data with ICES datasets [ Time Frame: 2 years ]
  • Validation of the accuracy of outcome data collected through registries and surveillance programs [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Erin Lillie, MSc

(437) 227-4458CLEANJoint@sunnybrook.ca

Locations

Health Sciences North

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Ryan Hodgins, MD FRCSC

(705) 522-9101rhodgins@hsnsudbury.ca

Principal Investigator:

Ryan Hodgins, MD FRCSC

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 24, 2026

Last verified

Mar, 2026

Keywords

  • prosthetic joint infection
  • registry-based RCT
  • PJI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-04-24.