NCT03614429

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

Status unknown Phase 2 Last updated 14 August 2018

What this trial tests

Phase 2 trial testing Chlorhexidine gel will be prepared according to an international product Instillagel® in Penile Prosthesis; Complications in 100 participants. Status unknown.

Timeline

1 June 2018

Primary endpoint
1 December 2018

1 December 2018

Quick facts

Lead sponsor	Cairo University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	1 June 2018
Primary completion	1 December 2018
Estimated completion	1 December 2018
Sites	1 location across Egypt

Drugs / interventions tested

• Chlorhexidine gel will be prepared according to an international product Instillagel® — full drug profile →

Conditions studied

• Penile Prosthesis; Complications — all drugs for Penile Prosthesis; Complications →

Sponsor

Cairo University

Who can join

Adults 21 to 50, male only, with Penile Prosthesis; Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.