Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05405907 |
| Other study ID # |
12345 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
University Hospital Birmingham NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
