A new multicentre study investigating PuraStat efficacy, safety, and ease of use for haemostasis in endonasal surgery (turbinate reduction, septoplasty and FESS).
Bleeding is a common intraoperative and/or post-operative issue in Endoscopic Endonasal Surgery (EES). To manage bleeding at the end of the procedure, different tools are currently used such as diathermy, nasal packing and topical haemostatic agents. It is acknowledged that excessive use of cautery may facilitate adhesion formation and crusting.
In the publication “RADA16, a Self-Assembling Peptide (Sap) For Haemostasis in Nasal Endoscopic Surgery, a Case Series in Australia” (2022) by Dr Soodin et al., the authors assessed the clinical performance for haemostasis and safety of RADA16 2.5% (PuraStat), in patients undergoing endonasal surgery including turbinate reduction, septoplasty and FESS procedures.
The study was designed as a multicentre case series and involved 167 patients treated by 9 senior surgeons over an 18-month period in Australia. The primary objective was to assess the effectiveness of PuraStat in stopping intraoperative nasal bleeding. The secondary objectives included the rate of adhesion formation and the level of crusting.
The results were as follows:
- Haemostatic efficacy: 98.2%
- Product was found to be easy to use and easy to apply, overall satisfaction: (4.8/5)
- Low incidence of adhesions requiring additional treatment (4.2%)
- Minimal crusting
- No adverse events were reported.
In this study, PuraStat was shown to be effective in achieving intraoperative haemostasis in a wide variety of endonasal surgery scenarios. Additionally, in this study, a low rate of adhesion formation was observed.
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Please, read carefully PuraStat’s instructions for use, indications and contraindications of the product1.
1PuraStat IFU-007 Rev 2.