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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06275646
Other study ID # Adeel2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date April 1, 2023

Study information

Verified date February 2024
Source Children Hospital and Institute of Child Health, Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date April 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Male
Age group 6 Months to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PRP layer
platelet rich plasma layer was applied in addition to dartos flap
dartos flap
dartos flap alone was used

Locations

Country Name City State
Pakistan The Children Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Children Hospital and Institute of Child Health, Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary wound infectiom local wound infection assessed by southampton wound assessment scale where 0 means excellent and 4 means worst 30 days
Primary frequency of glans dehiscence glans dehiscence observed 30 days
Primary frequency of meatal stenosis meatal stenosis assessed on examination 30 days
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