CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee

NCT05828810 | Recruiting

• 1 other identifier: 4000
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

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

Keywords

prosthetic joint infection; registry-based RCT; PJI

Outcome Measures

Primary Outcomes (6)

• Assessment of accrual

  Average number of patients enrolled per month: feasible if 10 or more overall

  2 years

• Ability to deliver intervention the patient is randomized to receive

  Feasible if \>90% of patients receive correct intervention

  2 years

• Ability to collect complete data from participants

  Feasible if \>80% of data is collected.

  2 years

• To estimate the aggregate incidence of reoperation for wound complication or PJI at one year

  Number of reoperations for wound complication or PJI within one year in each group

  2 years

• Ability to link collected outcome data with ICES datasets

  Feasible if linkage is possible in \>90% of participants.

  2 years

• Validation of the accuracy of outcome data collected through registries and surveillance programs

  a) Valid if \>90% agreement (sensitivity, specificity, positive predictive value, negative predictive value) for each outcome (collected at follow-up).

  2 years

Study Arms (2)

Chlorhexidine gluconate-alcohol solution

ACTIVE COMPARATOR

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.

Procedure: Chlorhexidne Gluconate-Alcohol Skin Preparation

Povidone-iodine solution

ACTIVE COMPARATOR

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.

Procedure: Poviodine-iodine Skin Preparation

Interventions

Chlorhexidne Gluconate-Alcohol Skin Preparation PROCEDURE

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.

Chlorhexidine gluconate-alcohol solution

Poviodine-iodine Skin Preparation PROCEDURE

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.

Povidone-iodine solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (3)

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

ACTIVE NOT RECRUITING

Health Sciences North

Greater Sudbury, Ontario, P3E 5J1, Canada

RECRUITING

Sunnybrook Holland Centre

Toronto, Ontario, M4Y 1H1, Canada

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Raman Mundi, MD MSc FRCSC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Lillie, MSc

CONTACT

(437) 227-4458; CLEANJoint@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analysts will be blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicentre, pragmatic, open label, 2-arm parallel-group Vanguard feasibility RCT.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: July 25, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)