Clinical trial NCT05405907: Evaluation of the Haemostatic Agent Purabond in ENT TORS
Official title: Evaluation of the Haemostatic Agent Purabond in ENT TORS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients undergoing ENT transoral robotic surgery (TORS) with Purabond application between August 2021 - May 2022 at a single centre teaching university hospital National Health Service trust

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.

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.

Eligibility 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

Primary outcomes:
measure: Primary haemorrhage
timeFrame: 24 hours post operatively
measure: Secondary haemorrhage
timeFrame: Day 1 to day 30 post operatively
Secondary outcomes:
measure: Readmission
timeFrame: Within 30 days post operatively
measure: Feeding tube
timeFrame: Within 30 days post operatively
measure: Tracheostomy tube
timeFrame: Within 30 days post operatively
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Trust
Study officials:
affiliation: ENT registrar
name: Keshav Gupta, MBBS
role: PRINCIPAL_INVESTIGATOR
References: