Evidence map›Paper›PMID 39434728›Full record

ArticleTranslational andrology and urology2024

Comparing 0.05% chlorhexidine gluconate monotherapy to conventional antibiotic irrigation in

Elsayed Desouky, Peter Tsambarlis, Laurence A Levine

Registry-linked trialAbstract read
In one paragraph

Article in Translational andrology and urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06489431 (Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06489431 phase3active not recruitingnot on this map

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority Trial

TypeinterventionalSponsorRush University Medical CenterRan2023 to 2027Enrolled200ConditionsErectile Dysfunction, Penile Prosthesis, Complications, Infection or InflammationArmsChlorhexidine, Gentamicin, Rifampin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Elsayed DesoukyGlickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.
Peter TsambarlisUrology Department, Northwestern University Hospital, Chicago, IL, USA.
Laurence A LevineUrology Department, RUSH University Medical Center, Chicago, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: 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 Methods: 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. Results: 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. Conclusions: 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. Trial Registration: ClinicalTrials.gov NCT06489431.

Indexed as

antisepticinfectionirrigationPenile prosthesis (PP)

Identifiers

PMID39434728
PMCPMC11491223

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.