EFFICACY OF RADA-16 SELF-ASSEMBLING PEPTIDE HYDROGEL IN THE MANAGEMENT OF EPISTAXIS: A SYSTEMATIC REVIEW

Abstract

ABSTRACT

Epistaxis is a common condition in otolaryngology with a significant clinical burden, particularly in postoperative settings and patients with hereditary hemorrhagic telangiectasia (HHT). The self-assembling peptide hydrogel RADA-16 has emerged as a novel hemostatic agent. This systematic review aimed to evaluate the effectiveness and safety of RADA-16 in epistaxis management. The review followed the PRISMA 2020 guidelines, with literature searches conducted in PubMed, the Cochrane Library, and Google Scholar. Randomized controlled trials and observational studies evaluating RADA-16 for epistaxis were included. Outcomes included hemostatic success, rebleeding, additional interventions, patient comfort, and complications. Risk of bias was assessed using the Joanna Briggs Institute tools, and data were synthesized narratively. Five studies involving 1,298 patients were included: one randomized controlled trial, two cohort studies, and two case series, with most evidence derived from observational studies. RADA-16 demonstrated high hemostatic effectiveness across clinical settings. A large cohort study (n = 985) reported lower postoperative bleeding compared with standard care (0.35% vs. 2.17%), while a multicenter case series (n = 167) reported 98.2% hemostatic success and 4.2% adhesion. In patients with HHT (n = 22), the Epistaxis Severity Score decreased by 2.0 points. No serious adverse events were reported. Overall, RADA-16 shows potential as a safe and effective hemostatic agent, although evidence remains limited by study heterogeneity and the predominance of observational designs. High-quality randomized trials are needed to confirm its effectiveness and safety.

ABSTRAK

Epistaksis merupakan kondisi yang umum dijumpai dalam bidang otolaringologi dengan beban klinis yang signifikan, terutama pada kondisi pascaoperasi dan pasien dengan hereditary hemorrhagic telangiectasia (HHT). Hidrogel peptida self-assembling RADA-16 telah muncul sebagai agen hemostatik baru. Tinjauan sistematis ini bertujuan mengevaluasi efektivitas dan keamanan RADA-16 dalam penatalaksanaan epistaksis. Tinjauan dilakukan sesuai pedoman PRISMA 2020 melalui penelusuran literatur pada PubMed, Cochrane Library, dan Google Scholar. Studi uji terkontrol secara acak dan studi observasional yang mengevaluasi penggunaan RADA-16 untuk epistaksis disertakan. Luaran meliputi keberhasilan hemostasis, perdarahan ulang, kebutuhan intervensi tambahan, kenyamanan pasien, dan komplikasi. Risiko bias dievaluasi menggunakan Joanna Briggs Institute dan data disintesis secara naratif. Lima studi dengan 1.298 pasien disertakan, terdiri atas satu uji terkontrol secara acak, dua studi kohort, dan dua seri kasus, dengan sebagian besar bukti berasal dari studi observasional. RADA-16 menunjukkan efektivitas hemostatik yang tinggi pada berbagai kondisi klinis. Studi kohort (n = 985) melaporkan perdarahan pascaoperasi yang lebih rendah dibandingkan perawatan standar (0,35% vs. 2,17%), sedangkan seri kasus multisenter (n = 167) melaporkan keberhasilan hemostasis 98,2% dan adhesi 4,2%. Pada pasien HHT (n = 22), Epistaxis Severity Score menurun 2,0 poin. Tidak dilaporkan kejadian tidak diinginkan yang serius. RADA-16 berpotensi sebagai agen hemostatik yang aman dan efektif, tetapi bukti masih terbatas oleh heterogenitas studi dan dominasi desain observasional. Uji klinis acak berkualitas tinggi diperlukan untuk memperkuat bukti efektivitas dan keamanannya.