Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520423
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents With Hypospadias
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Urethral Stent Irrigation in Preventing Surgical Site Infections in Adolescents With Hypospadias A Prospective Cluster-Randomized Crossover Multicenter Study
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unauthorized registration by a non-account owner permission not granted The registration number needs to be withdrawn
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective cluster-randomized crossover two-arm controlled clinical trial aims to determine whether urethral stent tube irrigation combined with urinary catheter drainage prevents postoperative wound infections compared to urinary catheter drainage alone in adolescents with hypospadias
Detailed Description:
Hypospadias is one of the most common genital developmental malformations in pediatric patients with a prevalence of approximately 05 The primary manifestations of hypospadias include an ectopic urethral opening penile recurvature and abnormal distribution of the prepuce Currently urethroplasty is the only treatment for hypospadias with surgery recommended within the first three years of life However due to economic cultural and social factors many children miss the optimal age for surgery and require initial or re-repair surgery during puberty Additionally some children who underwent hypospadias repair before puberty develop penile recurvature and other complications during adolescence necessitating reoperation Physiological changes during puberty such as penile growth pubic hair development increased skin appendages secretions and frequency of erections increase the risk of wound infection and poor healing post-surgery To address these issues we placed a stent in the reconstructed urethra of adolescents with hypospadias and performed urethral irrigation postoperatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None