Efficacy of the preformulated irrigation solution Bactisure® in acute periprosthetic joint infection debridement surgery: study protocol for a randomized controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Acetic Acid* ; Arthroplasty, Replacement, Knee*/adverse effects ; Debridement* ; Prosthesis-Related Infections*/microbiology ; Prosthesis-Related Infections*/diagnosis ; Therapeutic Irrigation*/methods; Humans ; Anti-Bacterial Agents/administration & dosage ; Anti-Bacterial Agents/therapeutic use ; Arthroplasty, Replacement, Hip/adverse effects ; Arthroplasty, Replacement, Hip/methods ; Biofilms/drug effects ; Biofilms/growth & development ; Ethanol/administration & dosage ; Hip Prosthesis/microbiology ; Hip Prosthesis/adverse effects ; Knee Prosthesis/adverse effects ; Knee Prosthesis/microbiology ; Prospective Studies ; Randomized Controlled Trials as Topic ; Saline Solution/administration & dosage ; Treatment Outcome

Background: Despite significant progress in orthopaedic surgery, the prevalence of periprosthetic joint infections (PJIs) remains persistent, and future increases are expected due to the increasing number of joint arthroplasties. PJIs are intricately connected to biofilm-producing bacteria, which encase infected prostheses, impairing the effectiveness of antibiotics and the immune system. Acute PJIs with immature biofilms are traditionally managed with debridement, antibiotics, and implant retention (DAIR). However, to date, there has not been a conclusive direct clinical comparison (in vivo) demonstrating the superiority of one irrigation solution over others. Recently, there has been a growing interest in irrigation solutions with antibiofilm properties demonstrated in in vitro studies, exemplified by the preformulated Bactisure® irrigation solution, which contains ethanol, acetic acid, sodium acetate, benzalkonium chloride, and sterile water. The main objective of this study was to evaluate the effectiveness (infection cure rate) of preformulated Bactisure® irrigation solution in vivo compared with saline solution in a control group of patients with acute knee and/or hip periprosthetic infections treated with DAIR.
Methods: Prospective single-centre randomized controlled trial involving patients with acute haematogenous PJI who received standard DAIR surgery from December 2022 to December 2024. The type of irrigation solution used during surgery will include two groups allocated at a 1:1 ratio: a control group (n = 25) with saline solution and an experimental group (n = 25) receiving the Bactisure® preformulated solution. The sample size was calculated based on an expected reduction in reinfection rates from 45% in the control group to 10% in the experimental group. Data on baseline patient characteristics, clinical and radiological information, and healthcare questionnaires will be recorded. All patients will be followed for minimum of 12 months. The infection cure rate at 1 year will be the primary outcome.
Discussion: This study is the first to compare the effectiveness of preformulated Bactisure® irrigation solution with that of saline solution in real clinical practice (in vivo) in patients with acute knee and/or hip periprosthetic infections treated with DAIR. Our main hypothesis is that, compared with saline solution, Bactisure® provides a better infection cure rate at 1 year post-DAIR.
Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696 . Registered on December 19, 2023.
Competing Interests: Declarations Ethics approval and consent to participate Ethical approval was obtained on 25/11/2022 from the Clinical Research Ethics Committee (CEIm) of Vall d’Hebron University Hospital (Pg. Vall d’Hebron, 119–129, Barcelona, 08035, Spain; (+ 34) 934893891; [email protected]) under reference number PR(AT)192/2022. Written consent from patients will be obtained before their participation in the study. The study is registered with the International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696 (registered on 19/12/2023). Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests.
(© 2024. The Author(s).)

Erratum in: Trials. 2024 Dec 1;25(1):804. doi: 10.1186/s13063-024-08663-z. (PMID: 39617878)

Waddell BS, Briski DC, Meyer MS, Ochsner JL, Chimento GF. Financial analysis of treating periprosthetic joint infections at a tertiary referral center. J Arthroplasty. 2016;31:952–6. (PMID: 10.1016/j.arth.2015.10.04326703194)
Bozic KJ, Kurtz SM, Lau E, Ong K, Chiu V, Vail TP, et al. The epidemiology of revision total knee arthroplasty in the United States. Clin Orthop. 2010;468:45–51. (PMID: 10.1007/s11999-009-0945-019554385)
Kurtz SM, Ong KL, Schmier J, Zhao K, Mowat F, Lau E. Primary and revision arthroplasty surgery caseloads in the United States from 1990 to 2004. J Arthroplasty. 2009;24:195–203. (PMID: 10.1016/j.arth.2007.11.01518534428)
Balato G, Ascione T, de Matteo V, Lenzi M, Amato M, de Giovanni R, et al. Debridement and implant retention in acute hematogenous periprosthetic joint infection after knee arthroplasty: a systematic review. Orthop. Rev. 2022;14. Available from: https://www.orthopedicreviews.openmedicalpublishing.org/article/33670  Cited 2022 Dec 5.
Kunutsor SK, Beswick AD, Whitehouse MR, Wylde V, Blom AW. Debridement, antibiotics and implant retention for periprosthetic joint infections: a systematic review and meta-analysis of treatment outcomes. J Infect. 2018;77:479–88. (PMID: 10.1016/j.jinf.2018.08.01730205122)
Veerman K, Raessens J, Telgt D, Smulders K, Goosen JHM. Debridement, antibiotics, and implant retention after revision arthroplasty: antibiotic mismatch, timing, and repeated DAIR associated with poor outcome. Bone Jt J. 2022;69(3):455–66.
Nucci N, Gazendam A, Gouveia K, Ghert M, Wilson D. Management of infected extremity endoprostheses: a systematic review. Eur J Orthop Surg Traumatol. 2020;30:1139–49. (PMID: 10.1007/s00590-020-02699-y32405759)
van Meurs SJ, Gawlitta D, Heemstra KA, Poolman RW, Vogely HC, Kruyt MC. Selection of an optimal antiseptic solution for intraoperative irrigation: an in vitro study. J Bone Jt Surg. 2014;96:285–91. (PMID: 10.2106/JBJS.M.00313)
FLOW Investigators; Petrisor B, Sun X, Bhandari M, Guyatt G, Jeray KJ, Sprague S, Tanner S, Schemitsch E, Sancheti P, Anglen J, Tornetta P, Bosse M, Liew S, Walter S. Fluid lavage of open wounds (FLOW): a multicenter, blinded, factorial pilot trial comparing alternative irrigating solutions and pressures in patients with open fractures. J Trauma. 2011;71(3):596–606.
Siddiqi A, Abdo ZE, Springer BD, Chen AF. Pursuit of the ideal antiseptic irrigation solution in the management of periprosthetic joint infections. J Bone Jt Infect. 2021;6:189–98. (PMID: 10.5194/jbji-6-189-2021341091038182666)
Wood T, Ekhtiari S, Mundi R, Citak M, Sancheti PK, Guerra-Farfan E, et al. The effect of irrigation fluid on periprosthetic joint infection in total hip and knee arthroplasty: a systematic review and meta-analysis. Cureus. 2020. Available from: https://www.cureus.com/articles/29232-the-effect-of-irrigation-fluid-on-periprosthetic-joint-infection-in-total-hip-and-knee-arthroplasty-a-systematic-review-and-meta-analysis  Cited 2022 Feb 27. .
Ruder JA, Springer BD. Treatment of periprosthetic joint infection using antimicrobials: dilute povidone-iodine lavage. J Bone Jt Infect. 2017;2:10–4. (PMID: 10.7150/jbji.16448285298595423577)
Kobayashi N, Kamono E, Maeda K, Misumi T, Yukizawa Y, Inaba Y. Effectiveness of diluted povidone-iodine lavage for preventing periprosthetic joint infection: an updated systematic review and meta-analysis. J Orthop Surg. 2021;16:569. (PMID: 10.1186/s13018-021-02703-z)
Premkumar A, Nishtala SN, Nguyen JT, Bostrom MPG, Carli AV. The AAHKS Best Podium Presentation Research Award: comparing the efficacy of irrigation solutions on staphylococcal biofilm formed on arthroplasty surfaces. J Arthroplasty. 2021;36:S26-32. (PMID: 10.1016/j.arth.2021.02.03333750633)
Hunter C, Duncan S. Clinical effectiveness of a biofilm disrupting surgical lavage in reducing bacterial contamination in total knee arthroplasty revision surgery in known cases of prosthetic joint infection. 2019. Available at: https://www.zimmerbiomet.com/content/dam/zb-corporate/en/products/specialties/surgical/bactisure-wound-lavage/2656.1%20USen%20Bactisure%20White%20Paper.pdf.:10 .
Whitely ME, Helms SM, Muire PJ, Lofgren AL, Lopez RA, Wenke JC. Preclinical evaluation of a commercially available biofilm disrupting wound lavage for musculoskeletal trauma. J Orthop Surg. 2022;17:347. (PMID: 10.1186/s13018-022-03199-x)
Kia C, Cusano A, Messina J, Muench LN, Chadayammuri V, McCarthy MB, Umejiego E, Mazzocca AD. Effectiveness of topical adjuvants in reducing biofilm formation on orthopedic implants: an in vitro analysis. J Shoulder Elb Surg. 2021;30:2177–83. (PMID: 10.1016/j.jse.2020.12.009)
O’Donnell JA, Wu M, Cochrane NH, Belay E, Myntti MF, James GA, et al. Efficacy of common antiseptic solutions against clinically relevant microorganisms in biofilm. 2021;103:8.
Siddiqi A, Abdo ZE, Rossman SR, Kelly MA, Piuzzi NS, Higuera CA, et al. What is the optimal irrigation solution in the management of periprosthetic hip and knee joint infections? J Arthroplasty. 2021;36:3570–83. (PMID: 10.1016/j.arth.2021.05.03234127346)
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacotherapeutics. 2010;1(2):100–7. (PMID: 10.4103/0976-500X.72352)
Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586–e7586. (PMID: 10.1136/bmj.e7586233038843541470)
Abdelaziz H, Rademacher K, Suero EM, Gehrke T, Lausmann C, Salber J, et al. The 2018 international consensus meeting minor criteria for chronic hip and knee periprosthetic joint infection: validation from a single center. J Arthroplasty. 2020;35:2200–3. (PMID: 10.1016/j.arth.2020.03.01432247671)
Parvizi J, Tan TL, Goswami K, Higuera C, Della Valle C, Chen AF, et al. The 2018 definition of periprosthetic hip and knee infection: an evidence-based and validated criteria. J Arthroplasty. 2018;33:1309-1314.e2. (PMID: 10.1016/j.arth.2018.02.07829551303)
Shoji MM, Chen AF. Biofilms in periprosthetic joint infections: a review of diagnostic modalities, current treatments, and future directions. J Knee Surg. 2020;33:119–31. (PMID: 10.1055/s-0040-170121431935760)
Rodríguez-Pardo D, Pigrau C, Lora-Tamayo J, Soriano A, Del Toro MD, Cobo J, et al. Gram-negative prosthetic joint infection: outcome of a debridement, antibiotics and implant retention approach. A large multicentre study. Clin Microbiol Infect. 2014;20:O911-9. (PMID: 10.1111/1469-0691.1264924766536)
Choo KJ, Austin M, Parvizi J. Irrigation and debridement, modular exchange, and implant retention for acute periprosthetic infection after total knee arthroplasty. JBJS Essent Surg Tech. 2019;9(4):e38.1-2. (PMID: 10.2106/JBJS.ST.19.00019320517826974313)
Christopher ZK, Deckey DG, Pollock JR, Spangehl MJ. Antiseptic irrigation solutions used in total joint arthroplasty: a critical analysis review. JBJS Rev. 2022;10. Available from:  https://journals.lww.com/10.2106/JBJS.RVW.21.00225 . Cited 2022 Dec 1.
Dudareva M, Kümin M, Vach W, Kaier K, Ferguson J, McNally M, et al. Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): a randomised controlled open-label non-inferiority trial of duration of systemic antibiotics in adults with orthopaedic infection treated operatively with local antibiotic therapy. Trials. 2019;20:693. (PMID: 10.1186/s13063-019-3832-3318156536902346)

Keywords: Debridement antibiotic and implant retention (DAIR); Hip; Irrigation solution; Knee; Periprosthetic joint infection

Q40Q9N063P (Acetic Acid)
0 (Anti-Bacterial Agents)
3K9958V90M (Ethanol)
0 (Saline Solution)

Date Created: 20241116 Date Completed: 20241117 Latest Revision: 20241201

20241204

PMC11568522

10.1186/s13063-024-08637-1

39550574