Desouky Elsayed, Tsambarlis Peter, Levine Laurence A
Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.
Urology Department, Northwestern University Hospital, Chicago, IL, USA.
Transl Androl Urol. 2024 Sep 30;13(9):1905-1911. doi: 10.21037/tau-24-278. Epub 2024 Sep 26.
Infection remains a significant concern following penile prosthesis (PP) implantation surgery. Published guidelines have indicated the use of pre-operative intravenous (IV) antibiotics but have not provided specific recommendations regarding intra-operative irrigation. For long in our practice, we have been using a combination of antibiotics for irrigation (rifampin 600 mg/L of sterile water, gentamicin 80 mg/L of sterile water). Recently, 0.05% chlorhexidine gluconate (CHG) (Irrisept) (Irrimax Corp, Lawrenceville, GA, USA), has shown promise as an alternative irrigant, with potential advantages in terms of cost, ease of administration and reduced antibiotic resistance risk. The study aims to assess the non-inferiority of CHG antiseptic irrigation compared to conventional combined antibiotic irrigation in preventing postoperative infections for men undergoing de-novo PP implantation.
This is a two-center Institutional Review Board (IRB) approved prospective randomized controlled non inferiority trial, involving men undergoing de-novo PP implantation with a predetermined non-inferiority margin of 4%. Patients were randomly assigned into one of two groups: the CHG irrigation or the group receiving conventional antibiotic irrigation. All patients received IV antibiotics preoperatively and were sent home on oral antibiotics for 2 weeks post-operatively. The primary endpoint of this trial was to evaluate the incidence of PP infections. Secondary objectives encompassed the assessment of simplicity of use and cost-effectiveness.
A hundred patients were enrolled in our study so far (50 in each arm). Only one case of PP infection necessitating explanation was reported in each arm. Moreover, the use of CHG irrigation offered the potential advantages of ease of administration and less cost as compared to antibiotic irrigation solutions.
Preliminary data from this non-inferiority study demonstrate that CHG irrigation is non-inferior to conventional antibiotic irrigation in preventing postoperative infection following PP implantation. These findings support the consideration of CHG irrigation as a viable alternative during PP implantation, offering both clinical effectiveness and potential cost savings as well as reducing the risk of antibiotic resistance.
ClinicalTrials.gov NCT06489431.
阴茎假体（PP）植入手术后感染仍是一个重大问题。已发布的指南指出术前应使用静脉注射（IV）抗生素，但未就术中冲洗提供具体建议。长期以来，我们在实践中一直使用抗生素组合进行冲洗（利福平600毫克/升无菌水，庆大霉素80毫克/升无菌水）。最近，0.05%葡萄糖酸氯己定（CHG）（Irrisept）（Irrimax公司，美国佐治亚州劳伦斯维尔）已显示出作为替代冲洗剂的前景，在成本、给药便利性和降低抗生素耐药性风险方面具有潜在优势。本研究旨在评估与传统联合抗生素冲洗相比，CHG防腐冲洗在预防初次PP植入男性术后感染方面的非劣效性。
这是一项经两个中心机构审查委员会（IRB）批准的前瞻性随机对照非劣效性试验，涉及接受初次PP植入的男性，预定非劣效性 margin 为4%。患者被随机分为两组之一：CHG冲洗组或接受传统抗生素冲洗组。所有患者术前均接受静脉注射抗生素，并在术后口服抗生素2周后出院。本试验的主要终点是评估PP感染的发生率。次要目标包括评估使用的简便性和成本效益。
到目前为止，我们的研究共纳入了100名患者（每组50名）。每组仅报告了1例需要解释的PP感染病例。此外，与抗生素冲洗液相比，使用CHG冲洗具有给药简便和成本较低的潜在优势。
这项非劣效性研究的初步数据表明，在预防PP植入术后感染方面，CHG冲洗不劣于传统抗生素冲洗。这些发现支持在PP植入期间考虑将CHG冲洗作为一种可行的替代方法，既具有临床有效性，又可能节省成本，并降低抗生素耐药性风险。
ClinicalTrials.gov NCT06489431。
