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Urethral Sterilization With Chlorhexidine Digluconate to Facilitate Primary Repair & Same-Session Implantation

NCT03614429 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-08-14

No results posted yet for this study

Summary

The introduction of penile implants has revolutionized the management of male erectile dysfunction. However, a number of intraoperative complications may occur, which have a major impact on clinical outcomes and patient satisfaction such as bleeding, infection and urethral injury.

Patients undergoing penile implant surgery with fibrotic corpora (e.g., after priapism, after infection, or with Peyronie disease) have a higher risk rates of urethral perforation. This may be related to previous scarring, the difficultly in dilating scarred and fibrotic corpora and its inherent risk of corporal crossover and urethral perforation.

This work examines the efficacy of pre-operative urethral sterilization in rendering the urethra as sterile as the skin of the genital area, with the skin sterilized as per the ISSM guidelines for penile prosthesis implantation, thereby allowing primary repair of urethral injuries should they occur, and implantation in the same setting, without a higher risk of infection.

The study will involve 100 male patients undergoing aseptic surgery (regardless the procedure). Patients will be divided into two groups:

Group 1: control group, n=50 Group 2: Chlorhexidine group (Ch group), n=50 Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed.

After conclusion of surgery and with the patient on the operative table, the following swabs will be obtained:

* A penile skin swab.
* A urethral swab. Skin and urethral swabs will be compared for bacterial colonization by culture and sensitivity, across the two groups.

Conditions

  • Penile Prosthesis; Complications

Interventions

DRUG

Chlorhexidine gel will be prepared according to an international product Instillagel®

Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed. Chlorhexidine gel will be prepared according to an international product; Instillagel®, used prior to urethral catheterization as analgesic / anti-septic, with the following composition: 6ml of Instillagel® gel contain: 117.6mg lidocaine hydrochloride, 3.1mg chlorhexidine digluconate, 3.8mg methyl hydroxybenzoate (E218), 1.6mg propyl hydroxybenzoate (E216) 11ml of Instillagel® gel contain: 215.7mg lidocaine hydrochloride, 5.8mg chlorhexidine digluconate, 6.9mg methyl hydroxybenzoate (E218), 2.9mg propyl hydroxybenzoate (E216) The other ingredients are: Hyetellose, propylene glycol\* (E 1520), sodium hydroxide and purified water. Intra-operatively, the Ch group will receive Chlorhexidine instillation again before surgery, while the control group will not.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-12-01
Completion
2018-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03614429 on ClinicalTrials.gov