Search Results (5)

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. Full article

Background and aims. Clinically significant delayed bleeding (CSDB) may complicate endoscopic colorectal submucosal dissection (ESD). We aimed to assess the efficacy of preventive measures for CSDB. Methods. We assessed the results of a prospective registry of colorectal ESD for laterally spreading lesions. We evaluated the effect of clip closure and PuraStat application on the prevention of CSDB. Results. A total of 40 patients with 41 colorectal ESDs were included. ESD was successful in 38 lesions (92.7%), 35 with R0 resection (92.1%) and 33 with curative resection (86.8%). CSDB occurred in 3 of 38 lesions (7.9%, 95% CI [1.7–21.4%]), exclusively after rectal ESD (3 of 22 rectal lesions vs. 0 of 16 colonic lesions, p = 0.249). Clip closure was more frequently used after colonic ESD (12 of 16 colonic lesions vs. 2 of 22 rectal lesions, p < 0.001) and was not protective for CSDB in the univariate analysis, even though no events occurred after clip closure (0 of 14 lesions with clip closure vs. 3 of 24 lesions without, p = 0.283). PuraStat was more frequently applied after ESD for rectal lesions (16 of 22 rectal lesions vs. 2 of 16 colonic lesions, p < 0.001) and was not protective for CSDB, with all three events occurring after PuraStat application (3 of 18 lesions with PuraStat application vs. 0 of 20 lesions without, p = 0.097). Conclusions. CSDB occurred exclusively after rectal ESD, and no predictive factors were identified in the univariate analysis. Clip closure and PuraStat application were not protective for CSDB. Full article

Background and Objectives: A novel synthetic self-assembling peptide, PuraStat, has been introduced as a hemostatic agent. This case series aimed to evaluate the clinical efficacy of PuraStat for gastrointestinal bleeding during emergency endoscopy. Cases: Twenty-five patients with gastrointestinal bleeding who had undergone emergency endoscopy with PuraStat between August 2021 and December 2022 were retrospectively examined. Six patients were receiving antithrombotic agents, and ten patients with refractory gastrointestinal bleeding had undergone at least one endoscopic hemostatic procedure. The breakdown of bleeding was gastroduodenal ulcer/erosion in 12 cases, bleeding after gastroduodenal or colorectal endoscopic resection in 4 cases, rectal ulcer in 2 cases, postoperative anastomotic ulcer in 2 cases, and gastric cancer, diffuse antral vascular ectasia, small intestinal ulcer, colonic diverticular bleeding, and radiation proctitis in each case. The method of hemostasis was only PuraStat application in six cases, and hemostasis in combination with high-frequency hemostatic forceps, hemostatic clip, argon plasma coagulation, and hemostatic agents (i.e., thrombin) in the remaining cases. Rebleeding was observed in three cases. Hemostatic efficiency was observed in 23 cases (92%). Conclusions: PuraStat has the expected hemostatic effect on gastrointestinal bleeding during emergency endoscopy. The use of PuraStat should be considered in emergency endoscopic hemostasis of gastrointestinal bleeding. Full article

Background and Objectives: Bleeding is one of the most feared and frequent adverse events in the case of EUS-guided drainage of WOPN using lumen-apposing metal stents (LAMSs) and of direct endoscopic necrosectomy (DEN). When it occurs, its management is still controversial. In the last few years, PuraStat, a novel hemostatic peptide gel has been introduced, expanding the toolbox of the endoscopic hemostatic agents. The aim of this case series was to evaluate the safety and efficacy of PuraStat in preventing and controlling bleeding of WOPN drainage using LAMSs. Materials and Methods: This is a multicenter, retrospective pilot study from three high-volume centers in Italy, including all consecutive patients treated with the novel hemostatic peptide gel after LAMSs placement for the drainage of symptomatic WOPN between 2019 and 2022. Results: A total of 10 patients were included. All patients underwent at least one session of DEN. Technical success of PuraStat was achieved in 100% of patients. In seven cases PuraStat was placed for post-DEN bleeding prevention, with one patient experiencing bleeding after DEN. In three cases, on the other hand, PuraStat was placed to manage active bleeding: two cases of oozing were successfully controlled with gel application, and a massive spurting from a retroperitoneal vessel required subsequent angiography. No re-bleeding occurred. No PuraStat-related adverse events were reported. Conclusions: This novel peptide gel could represent a promising hemostatic device, both in preventing and managing active bleeding after EUS-guided drainage of WON. Further prospective studies are needed to confirm its efficacy. Full article

Introduction: Recently, a novel self-assembling peptide hemostatic gel has become available in Japan. However, the safety and efficacy of this novel self-assembling peptide hemostatic gel remain unclear for bleeding after EST. The aim of this study was to evaluate the safety and efficacy of a novel self-assembling peptide hemostatic gel for bleeding after EST, and to perform a comparison to a conventional endoscopic hemostasis technique. Method: This retrospective study was carried out between January 2019 and October 2022. Patients who developed bleeding associated with EST were enrolled. The patients were divided into two groups based on the hemostasis technique used: a conventional hemostasis technique (Group A) or a novel self-assembling peptide hemostatic gel hemostasis technique (Group B). Result: A total of 62 patients (Group A, n = 36; Group B, n = 26) were included. Endoscopic hemostasis was initially obtained in 72.2% (26/32) of patients in Group A and in 88.4% (23/26) of patients in Group B, which was not significantly different (p = 0.1320). However, the procedure time was significantly shorter in Group B (mean, 9.38 min) compared with Group A (mean, 15.4 min) (p = 0.0103). There were no significant differences in the severity of bleeding between the two groups (p = 0.4530). Post-EST bleeding was observed in six patients (Group A, n = 4; Group B, n = 2). Adverse events were more frequently observed in Group A (n = 12) than in Group B (n = 1) (p = 0.0457). Conclusions: PuraStat application for EST bleeding might be safe and effective, and is comparable to the conventional endoscopic hemostasis technique, although further prospective randomized trials are needed. Full article