Presentation Authors: Alp Tuna Beksac*, Amr Elbakry, Kennedy Okhawere, Bheesham Dayal, David Paulucci, Jing Zhi Lo, Ketan Badani, New York, NY
Introduction: Dehydrated human amnion/chorion membrane allograft (dHACM) is a product with anti-inflammatory and regenerating properties. However, its&[prime] benefit in kidney tissue recovery has not been established. The aim of this study is to evaluate the benefit of dHACM in facilitating renal functional recovery post robotic partial nephrectomy (RPN).
Methods: We report the preliminary results of a phase II double arm single-blind randomized clinical trial. Sixty-one patients with a solitary cT1a renal mass were enrolled in the study. In the control arm, patients underwent RPN as the standard of care. In the treatment arm, dHACM was placed on the defect after renorrhaphy was complete. Renal functional outcome was evaluated at postoperative 2 weeks, 4 months and 12 months. We report the results of 61 participants with at least 4 months of follow-up. Baseline characteristics, perioperative and postoperative outcomes were compared between the two group using Mann-Whitney U, Chi-square and Fisher&[prime]s exact, and student&[prime]s t tests.
Results: Participants had a median age of 61 (IQR: 53, 68) years and both groups were similar regarding baseline demographics, clinical and tumor characteristics. (Table 1) No adverse events were seen associated with the use of dHACM. There were no differences seen between the two arms regarding warm ischemia time (p = 0.837), operative time (p = 0.675), estimated blood loss (p = 0.239), intra-operative complications (p = 0.290), length of hospital stay (p = 0.704), and adverse events at 4weeks (p =0.481). In terms of functional outcome, dHACM did not improve eGFR (p = 0.699) or change in eGFR (p = 0.532) at 4 months.
Conclusions: The early results demonstrate that use of dHACM did not improve eGFR in the short term. However, the use of dHACM is safe and not associated with an increased rate of early post-operative complications. Longer term follow up data is required to determine the potential benefits in this setting.
Source of Funding: MiMedx