Evaluation of the Haemostatic Agent Purabond in ENT TORS
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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.
Study Design
Outcome Measures
Primary Outcome Measures
- Primary haemorrhage [24 hours post operatively]
Haemorrhage
- Secondary haemorrhage [Day 1 to day 30 post operatively]
Haemorrhage
Secondary Outcome Measures
- Readmission [Within 30 days post operatively]
Hospital readmission
- Feeding tube [Within 30 days post operatively]
Nasogastric tube insertion
- Tracheostomy tube [Within 30 days post operatively]
Tracheostomy tube insertion
Eligibility Criteria
Criteria
Inclusion Criteria:
- all consecutive patients undergoing ENT transoral robotic surgery (TORS) with Purabond application between August 2021 - May 2022 at a single centre teaching university hospital NHS trust
Exclusion Criteria:
-
Purabond not applied
-
incomplete case notes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Birmingham NHS Trust | Birmingham | United Kingdom | B15 2TH |
Sponsors and Collaborators
- University Hospital Birmingham NHS Foundation Trust
Investigators
- Principal Investigator: Keshav Gupta, MBBS, ENT registrar
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12345