Safety of AlloDerm® with incomplete approximation of pubic bones in bladder exstrophy
Sahar Eftekharzadeh, MD, MPH1, Ted Lee, MD2, Elizabeth B. Roth, MD3, John Weaver, MD1, Jay Shah, BA1, Alyssia Venna, MBS2, Travis W. Groth, MD3, John V. Kryger, MD3, Aseem R. Shukla, MD1, Douglas A. Canning, MD1, Joseph G. Borer, MD2, Dana A. Weiss, MD1.
1The Children's Hospital of Philadelphia, Philadelphia, PA, USA, 2Boston Children's Hospital, Boston, MA, USA, 3Children's Wisconsin, Milwaukee, WI, USA.
BACKGROUND: Complete primary repair of exstrophy (CPRE) has been popularized as a single-staged bladder exstrophy repair that allows for early bladder cycling and ideally limits the number of major reconstructive surgeries required to achieve urinary continence. Complications of CPRE include penile and urethral/vaginal ischemia, bladder dehiscence, vesico-cutaneous fistulae (VCF) and skin breakdown. To prevent penile ischemia the pubic bones may not be re-approximated completely, leaving a gap that may predispose to early fistula formation. We hypothesize that (1) the use of AlloDerm® as an adjunct layer over the bladder neck is safe and (2) the fistula rate would remain the same in children who have incomplete approximation of the pubic bones in which AlloDerm® was used as in cases with near complete pubic rami approximation.
METHODS: We prospectively reviewed IRB-approved databases of children who underwent primary CPRE for classic bladder exstrophy (BE) between 2/2013 and 7/2020 as part of a three-center multi-institution collaboration. Pertinent peri-operative details were evaluated, including age at closure, use of AlloDerm®, type of osteotomy, type of traction, and pubic diastasis measurements (PDM) obtained via x-ray pre-operatively and immediately post-operatively following pubic bone re-approximation. In addition, the incidence of post-operative complications including bladder dehiscence, VCF and skin breakdown were reviewed.
RESULTS: Eighty-six patients underwent primary CPRE for BE during the period of collaboration; 78 (52 (67%) males), with a minimum follow-up of one year were included. Median age was 2 months (IQR: 2-3 months) at the time of initial closure. AlloDerm® was used in 20 (26%) patients. Immediate post-operative PDM was significantly higher (1.9 vs 1.5 cm, p=0.04) in those who had AlloDerm® placed than those who did not have AlloDerm® placed, and the percent reduction in pubic diastasis was significantly less (50.4% vs 59.3%, p=0.048) in those who had AlloDerm® placed. The incidence of persistent VCF (17% vs 10%, p=0.67) and skin breakdown (25% vs 9%, p=0.11) did not differ between those who were closed with or without AlloDerm®. No patient had a bladder dehiscence or developed skin breakdown.
CONCLUSIONS: Use of AlloDerm® in CPRE as a slip layer to cover the bladder neck is safe and does not lead to skin breakdown or increase skin breakdown. AlloDerm® was used more often in children who were left with a wider pubic diastasis following surgery due to concern for ischemia and still there was no difference in fistula formation compared to those with a tighter closure of the pubis without AlloDerm®. While further studies are needed to prove whether the use of AlloDerm® can prevent fistula despite incomplete pubic bone approximation, we demonstrate its safety and potential effectiveness. 
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