Evaluation of the Haemostatic Agent Purabond in ENT TORS

Hemorrhage Clinical Trial

Official title: Evaluation of the Haemostatic Agent Purabond in ENT TORS

Status Completed

Clinical Trial Summary

To evaluate the use of Purabond in ENT TORS for diagnostic and therapeutic procedures. Consecutive patients enrolled retrospectively via case note review. Outcome measures - primary and secondary haemorrhage, swallowing outcomes, need for nasogastric tube or tracheostomy, readmission.

Clinical Trial Description

Transoral robotic surgery (TORS) has been increasingly utilised in ear, nose and throat (ENT) Surgery over the past 20 years offering unprecedented 3-dimensional (3-D) views and enabling access to traditionally 'difficult-to-reach' tumours. It is now becoming a viable first line treatment option for oropharyngeal squamous cell carcinoma (OPSCC) compared to chemoradiotherapy. One of the main concerns is serious haemorrhage that can lead to death. PuraBond® (also known as PuraStat ®; 3D Matrix Ltd, Tokyo, Japan), which consists of the RADA16 family of synthetic peptides. PuraBond® is a self-assembling viscous solution that once applied on the surgical bed, it forms a transparent hydrogel 3-D matrix to achieve local haemostasis. Its transparent nature allows visualisation of the surgical field, permitting real-time assessment of intraoperative haemostasis. There are some studies demonstrating that it can promote healing. We aimed to assess the effect of Purabond in ENT TORS for diagnostic and therapeutic procedures such as oropharyngectomy and tongue base mucosectomy. Patients were enrolled from a single tertiary university hospital trust in the United Kingdom (University Hospitals Birmingham National Health Service Foundation Trust). Case notes for all patients were analysed retrospectively. Data extracted included patient demographics (age, sex, smoking history), procedure details (date, indication for surgery and type of TORS procedure) and tumour details (histopathology including p16 status and stage). The primary outcome measure was post-operative haemorrhage rate (primary; within 24 hours of surgery, and secondary; between 1-30 days post-surgery). Secondary outcome measures included, length of hospital stay (LOS), post-operative swallowing complications, in particular whether feeding tube insertion or tracheostomy was performed either prior to or within 30 days of surgery, hospital re- readmission rate within 30 days of surgery, and surgeon-reported ease of PuraBond® application. Descriptive statistical analysis was undertaken where applicable (mean, median, standard deviation) using Microsoft Excel® version 16.31. ;

Related Conditions & MeSH terms

• Hemorrhage

• NCT number: NCT05405907
• Study type: Observational
• Source: University Hospital Birmingham NHS Foundation Trust
• Status: Completed
• Start date: August 1, 2021
• Completion date: May 1, 2022