From Biomaterial Innovation to Surgical Practice: A Systematic Review of RADA16 Self-Assembling Peptide Hydrogel in Otolaryngology and Head & Neck Surgery

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Background: Postoperative bleeding is a frequent complication in otolaryngology and head and neck surgery, often leading to readmissions and increased healthcare costs. Objectives: This systematic review evaluates the clinical efficacy, safety, and impact of RADA16, a synthetic self-assembling peptide hydrogel, as a topical haemostatic adjunct in this surgical field. Methods: In adherence with PRISMA 2020 guidelines, a systematic search of PubMed, Scopus, and Web of Science was conducted through December 2025. Eligible studies included adult patients undergoing otolaryngological or head and neck surgical procedures where RADA16 (CAS 289042-25-7, PuraBond®/PuraStat®/PuraGel®, ®, 3-D Matrix SAS; Caluire et Cuire, Lyon, France) was applied intraoperatively. Exclusion criteria included non-English publications, reviews, and studies without clinical outcome data. Risk of bias was assessed using the Cochrane Risk of Bias tool for RCTs and the Newcastle-Ottawa Scale for observational studies. A narrative synthesis was performed due to heterogeneity in outcome reporting. Results: Eight studies involving 1761 patients were included. In oropharyngeal surgery, RADA16 significantly reduced postoperative haemorrhage (6.3% vs. 16.7%, p = 0.016) and was associated with faster resumption of normal diet and lower pain scores (p = 0.016). In nasal surgery, it significantly lowered epistaxis rates (0.4% vs. 2.2%, adjusted OR 0.027, p = 0.026) and reduced the need for nasal packing. In cervical endocrine surgery, the rate of hematoma requiring revision was low (0.84%), with no delayed bleeding beyond 24 h. Surgeons consistently reported high satisfaction and ease of application. No serious device-related adverse events were reported. Discussion: Current evidence suggests RADA16 is a safe and effective haemostatic adjunct that can improve postoperative recovery and reduce readmission rates in specific surgical contexts. Limitations include heterogeneity in study designs, small sample sizes in some domains, and a lack of long-term follow-up. Further large-scale randomized controlled trials are needed to quantify its economic impact and formalize its role in surgical pathways. Funding: This study was funded by 3-D Matrix Medical Technology for article processing charges. The funder had no role in study design, data collection, analysis, interpretation, or writing. Registration: This review was not registered in a systematic review registry.

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