Not Yet RecruitingPhase 4ACTRN12625000376448

Effect of XPERIENCE advanced surgical irrigation on Cutibacterium Acnes contamination in shoulder arthroplasty


Sponsor

Perth Orthopaedic and Sports Medicine Research Foundation

Enrollment

40 participants

Start Date

Jul 1, 2025

Study Type

Interventional

Conditions

Summary

The current study seeks to assess if the XPERIENCE® Advanced Surgical Irrigation (XASI) wash can reduce the incidence of Cutibacterium acnes (C. Acnes) pathogen contamination in shoulder arthroplasty surgery. XASI is an antibacterial irrigant employed at the time of surgery, and is currently in use in arthroplasty cases at Hollywood Private Hospital. Recruited patients will be randomized into two groups: 1) specimen swabs taken before receiving 500ml of XASI (Group 1), or 2) receiving 500ml of XASI before specimen swabs are taken (Group 2). Swabs will be taken from six different sites from around the skin incision and surgeon’s instruments. Swabs will then be transported to a single microbiology processing centre for analysis of C. Acnes antibacterial load. It is hypothesized that the XASI wash will reduce the incidence of bacterial contamination of C. acnes in the surgical field of patients undergoing primary shoulder arthroplasty.


Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 80 Yearss

Inclusion Criteria2

  • Age 40-80 years.
  • Clinical and radiographic diagnosis of end-stage shoulder arthritis, indicated for primary shoulder arthroplasty.

Exclusion Criteria3

  • Use of antibiotics within 2 weeks prior to the surgical procedure.
  • Cortisone injection into the shoulder within 3 months prior to the procedure.
  • Not willing to sign the Patient Consent Form relevant to the study.

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Interventions

The current study seeks to assess if the XPERIENCE® Advanced Surgical Irrigation (XASI) wash can reduce the incidence of Cutibacterium acnes (C. Acnes) pathogen contamination in shoulder arthroplasty

The current study seeks to assess if the XPERIENCE® Advanced Surgical Irrigation (XASI) wash can reduce the incidence of Cutibacterium acnes (C. Acnes) pathogen contamination in shoulder arthroplasty surgery. XASI is an intra-operative surgical irrigant employed to cleanse and remove debris including micro-organisms, from the surgical wound space. It was designed as a no-rinse intraoperative surgical irrigation solution. It consists of citric acid, sodium citrate, and sodium lauryl sulfate in water. Citric acid and sodium citrate serve as pH buffers and aid in metal ion chelation, while sodium lauryl sulfate acts as a surfactant, assisting in debris removal including micro-organisms. XASI will be placed into the wound (following skin incision and once the wound is opened to expose the shoulder joint) as a wash and allowed to remain in the surgical field until the shoulder arthroplasty procedure has been completed. Following the completion of the surgical procedure, the wound will then be washed appropriately with normal saline irrigation prior to wound closure. For each procedure, a 500ml container is emptied into the surgical wound site in all cases. Recruited patients will be randomized into two groups: 1) specimen swabs taken before receiving 500ml of XASI (Group 1, which is the control group for the purpose of the study), or 2) receiving 500ml of XASI before specimen swabs are taken (Group 2, which is the intervention group for the purpose of the study). All participants will therefore undergo the XPERIENCE® wash. Swabs will be taken from six different sites from around the skin incision and surgeon’s instruments, and is expected to add an extra 2-3 minutes to the operating time.


Locations(1)

Hollywood Private Hospital - Nedlands

WA, Australia

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