BACKGROUND/PURPOSEThe most frequent complication following hypospadias correction is fistula formation. Recently, fibrin glue has been employed as a 2nd layer covering the urethroplasty resulting in a reduction in the incidence of fistulas. Platelet-rich fibrin (PRF) is an autologous growth factor-rich source. Although the authors recommend the use of additional layers in hypospadias correction, there remains a controversy. In a trial to address this issue, our research was conducted to compare the accessibility of urethroplasty coverage using PRF to traditional local flaps, aiming to prevent fistula formation in hypospadias repair.PATIENTS AND METHODSThis is a prospective single-blinded randomized controlled study that involved 60 hypospadias cases admitted to Mansoura University Children Hospital's Pediatric Surgery department between March 2021 and March 2023. These 60 cases were randomly divided into 2 equal groups: (group A platelet-rich fibrin coverage membrane & group B local dartos flap as an additional layer). Both groups were compared regarding the rate of complications. All cases were evaluated regarding age at repair, type of hypospadias, urethral plate width, length of urethroplasty, and size of the 2nd layer. The blood loss and operative time were documented and post-operatively; the cases were assessed for the repair intactness, shape, and size of the neo-meatus, existence of any post-operative problems such as urethral fistula, urethral stricture, meatal stenosis, failure of the repair, or diverticulum. Statistical analysis was carried out following data collection.RESULTSThe median length of the 2nd layer in group A was 20 mm (range 15-23 mm) and in group B was 22.5 mm (range 19.5-25 mm) and the difference between the two groups was statistically significant (p = 0.012∗), while its median width in group A was 10 mm (range 10-11 mm) and in group B was 15 mm (range 10-18 mm) and also there was statistically significant difference (p = 0.001∗). The mean operative time in group A was 95.73 ± 11.9 min and in group B was 102.33 ± 10.32 min and there was a statistically significant difference (P < 0.001). The length of hospital stay in group A was 5.47 ± 1.11 days and in group B was 5.47 ± 0.89 days. The urethral fistula was detected in 4 cases of group A (13.3%) and 3 cases of group B (10%). The failure of repair was similar, one case of each group (3.3%). The meatal stenosis was reported in only one case of group A (3.4%) and 7 cases of group B (24.1%) (P = 0.02∗) and the difference was statistically significant. There were no reports of urethral strictures among the cases in either group over the follow-up period (mean 9 months, range 5-17 months).CONCLUSIONPRF patch may be employed as a coverage layer over the urethroplasty in repair of the distal hypospadias, especially in cases without accessible vascular flap with comparable outcome to traditional local flaps.TYPE OF STUDYA prospective single blinded randomized controlled trial (computer-generated numbers method).LEVEL OF EVIDENCELevel 2.
