Efficacy of PRF in Hypospadias Repair
Evaluating the Efficacy of Platelet-Rich Fibrin (PRF) in Hypospadias Repair: A Randomized Controlled Trial
Hypospadias is an anomaly characterized by an ectopic ventral urethral meatus, and an incomplete or hooded prepuce. Its incidence is estimated at 1 in 200-300 live male births, with variations across populations and severity types.
Successful hypospadias repair depends largely on optimal tissue healing and robust vascular support around the neourethra. Thus, many adjunctive techniques have been investigated to improve outcomes, including dartos flaps, tunica vaginalis flaps, and various tissue sealants.
In recent years, attention has turned toward biological augmentation strategies, particularly the use of platelet-rich plasma (PRP) and platelet-rich fibrin as a potential enhancer of wound healing.
Platelet-rich fibrin (PRF), a second-generation autologous platelet concentrate, has recently emerged as another promising biologic in tissue engineering.
This study aims to evaluate the effect of PRF application in primary hypospadias repair surgery and determine its effect in improving healing and reduction of postoperative complications.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
All patients included in the study will undergo primary hypospadias repair using the standardized Tubularized Incised Plate (TIP) urethroplasty technique (Snodgrassi procedure), under general anesthesia and by the same surgical team to minimize variability
Steps of the Surgical Procedure (Same for Both Groups):
1. Preoperative preparation:
IV antibiotics, sterile field setup, general anesthesia. 2. Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures.
3. application of PRF (Group A only):
- 8-10 mL of autologous blood is drawn into plain (non-anticoagulant) tubes according to the patient's weight and the size of the patch needed.
- The sample is immediately centrifuged using the single-spin method (typically 3,000 rpm (400x g) for 12 minutes).
This produces three layers:
- Top layer: acellular plasma (PPP)
- Middle layer: platelet-rich fibrin (PRF) clot
- Bottom layer: red blood cells The PRF clot is gently removed and compressed using a gauze to form a thin PRF membrane.
PRF membrane is fixed on top of the suture line as a first layer and under the incision line as a second layer and secured using a few resorbable polyglyconate 6/0 interrupted sutures.
4. Glansplasty and skin closure using standard techniques in both groups 5. Catheter and dressing:
- A soft catheter is left in place for 5-7 days.
- A mild compression dressing is applied.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mahmoud Mohamed Magdy El-Ansary, MSc
- Telefonnummer: +201114393349
- E-post: mahmoudmagdy99@hotmail.com
Studer Kontakt Backup
- Navn: Younan R. Samir, M.D.
- Telefonnummer: +201201255511
- E-post: dr_yona@live.com
Studiesteder
-
-
Abbasia
-
Cairo, Abbasia, Egypt, 11517
- Ain Shams University
-
Ta kontakt med:
- Younan R. Samir, M.D.
- Telefonnummer: +201201255511
- E-post: dr_yona@live.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Diagnosed with primary distal or mid-penile hypospadias.
- Eligible for first-time (primary) surgical repair using the TIP (Tubularized Incised Plate) technique.
Exclusion Criteria:
- previous hypospadias surgery.
- Associated severe chordee requiring staged repair or patient with crippled hypospadias.
- Children with systemic diseases that may impair wound healing (e.g., diabetes, immunodeficiency, malnutrition).
- Presence of bleeding or coagulation disorders.
- Medically Unfit for surgery.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group A TIP urethroplasty with autologous PRF
Undergoes TIP urethroplasty with intraoperative placement of autologous PRF onto the urethral plate.
|
Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures. Application of PRF where 8-10 mL of autologous blood is drawn into plain (non-anticoagulant) tubes and a thin PRF membrane is extracted which is fixed on top of the suture line as a first layer and under the incision line as a second layer and secured using a few resorbable polyglyconate 6/0 interrupted sutures. Glansplasty and skin closure using standard techniques and fixing catheter and dressing |
|
Aktiv komparator: Group B standard TIP urethroplasty without PRF
Undergoes standard TIP urethroplasty without PRF application
|
Urethral plate incision and tubularization over a 6-8 Fr stent using absorbable sutures. Glansplasty and skin closure using standard techniques and fixing catheter and dressing |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Urethrocutaneous fistula formation
Tidsramme: 6 months
|
Incidence of urethrocutaneous fistula formation
|
6 months
|
|
Parental satisfaction Assessment
Tidsramme: 6 months
|
Parental satisfaction assessed using a standardized questionnaire HOPE score
|
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Hany H. Gad, Professor, Ain Shams University
- Studieleder: Hossam M.H. ElAwady, Professor, Ain Shams University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Kjønnssykdommer
- Kjønnssykdommer, mannlige
- Mannlige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Medfødte abnormiteter
- Urogenitale abnormiteter
- Penile sykdommer
- Medfødte, arvelige og neonatale sykdommer og abnormiteter
- Hypospadier
Andre studie-ID-numre
- PRF Hypospaias 001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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