Bactisure® Irrigation Solution Evaluated in Clinical Trial for Periprosthetic Joint Infections
核心洞察
A prospective, single-center, randomized controlled trial is underway to assess the efficacy of Bactisure (搜索)® irrigation solution in treating acute periprosthetic joint infections (搜索) (PJI).
The study compares Bactisure (搜索)® to saline solution in patients undergoing debridement, antibiotics, and implant retention (DAIR) for knee or hip PJI.
The primary outcome is the infection cure rate at 12 months, with secondary outcomes including length of hospital stay and postoperative complications.
A clinical trial is currently underway at Vall d’Hebron University Hospital (搜索) in Barcelona, Spain, to evaluate the effectiveness of Bactisure (搜索)® irrigation solution in treating acute periprosthetic joint infections (搜索) (PJI) of the knee or hip. The study, a prospective, single-center, randomized controlled trial, aims to determine if Bactisure® improves infection cure rates compared to standard saline solution when used during debridement, antibiotics, and implant retention (DAIR) procedures.
Trial Design and Methodology
The trial, registered with the International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696, involves patients with acute haematogenous PJI who are undergoing standard DAIR surgery. Participants are randomized in a 1:1 ratio to receive either saline solution (control group) or Bactisure (搜索)® preformulated solution during the procedure. The study is single-blinded, meaning patients are unaware of which irrigation solution is used.
During DAIR surgery, a low-pressure pulsatile lavage system is used with the assigned irrigation solution:
- Group 1 (Saline): 9 L of saline solution (3 L, followed by 3 L, then 3 L).
- Group 2 (Bactisure®): 3 L of saline solution, followed by 1 L of Bactisure®, and then 3 L of saline solution.
Inclusion and Exclusion Criteria
Patients meeting specific inclusion criteria are offered the option to participate after being fully informed. All participants must sign an informed consent form. Data collection continues for 12 months post-surgery, with regular backups and secure storage to ensure data integrity. Patient identification is managed using numerical codes to maintain privacy, and all investigators have signed confidentiality agreements.
Primary and Secondary Outcomes
The primary outcome is the infection cure rate at the 12-month follow-up, defined by the absence of local recurrence (dehiscence, exudation, or fistula), no radiographic evidence of osteolysis (搜索), no ongoing suppressive antibiotic treatment, absence of reinterventions, and no deaths related to periprosthetic infection.
Secondary outcome measurements include:
- Length of hospital stay (days).
- Postoperative complications (e.g., infections, reoperations, osteolysis).
- Microorganisms identified on perioperative cultures.
Sample Size and Statistical Analysis
The trial aims to enroll 50 subjects (25 in each group) to detect a statistically significant difference in reinfection rates, assuming a reduction from 45% in the control group to 10% in the Bactisure (搜索)® group, with a statistical power of 80%. Data will be analyzed using R software, with a significance level of p < 0.05. An interim safety analysis will be performed after the first 12 patients in each group complete their interventions.
Dissemination of Results
The study protocol will be published in a peer-reviewed, open-access journal. Upon completion, the trial's findings will be presented at national and international meetings and published in high-impact medical and orthopaedic journals.