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OpenTrials
Completed

NCT Number: NCT06275646

Comparison Of Outcome Of Different Layers in Hypospadias Surgery

To compare the outcome of applying autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery. A total of 220 patients fulfilling the selection criteria were admitted after taking informed consent. Cases were randomly divided into groups A and B using a random generator of the Excel program. In group A, dartos flap and PRP sheet layer were applied and in group B, only a preputial dartos fascial flap was applied

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Key information

Conditions

Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Penile Diseases Urogenital Abnormalities Urogenital Diseases

Age range

6 month–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Children Hospital

Lahore, Punjab Province, 42000, Pakistan

About this study

Objective To compare the outcome of application of autologous platelet-rich plasma membrane layer and dartos fascial flap versus only dartos fascial flap in mid and distal penile hypospadias surgery.

Methods This randomized controlled trial was conducted at Pediatric General surgical department, the Children's hospital and the University of Child health, Lahore for the period of 12 months. Non probability, purposive sampling was used for data collection and randomization was done to assign the treatment. Total of 220 patients fulfilling the selection criteria were admitted after taking an informed consent. Cases were randomly divided into two groups A and B using random generator of Excel program. In group-A, dartos flap and PRP sheet layer was applied and in group-B, only a preputial dartos fascial flap was applied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients (Age 6months to12 years) with mid, distal penile or sub coronal hypospadias having minimal chordae were included in the study

Exclusion criteria

  • Patients having proximal hypospadias, moderate to severe chordae, previously operated cases, a preoperative androgens treatment (for example in penoscrotal hypospadias and small sized phallus) were excluded from study

Treatment and study plan

PRP layer

Other

platelet rich plasma layer was applied in addition to dartos flap

dartos flap

Other

dartos flap alone was used

Primary outcomes

  1. wound infectiom

    Time frame: 30 days

    local wound infection assessed by southampton wound assessment scale where 0 means excellent and 4 means worst

  2. frequency of glans dehiscence

    Time frame: 30 days

    glans dehiscence observed

  3. frequency of meatal stenosis

    Time frame: 30 days

    meatal stenosis assessed on examination

Sponsors and collaborators

Lead sponsor

Children Hospital and Institute of Child Health, Lahore

Other

Registry information

Official study title

Comparison Of Outcome Of Autologus Platelet Rich Plasma Membrane Plus Dartos Flap Versus Simple Dartos Flap In Hypospadias Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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