NCT05405907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

9 months

First QC Date

May 27, 2022

Last Update Submit

June 1, 2022

Conditions

Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • Primary haemorrhage

    Haemorrhage

    24 hours post operatively

  • Secondary haemorrhage

    Haemorrhage

    Day 1 to day 30 post operatively

Secondary Outcomes (3)

  • Readmission

    Within 30 days post operatively

  • Feeding tube

    Within 30 days post operatively

  • Tracheostomy tube

    Within 30 days post operatively

Interventions

PuraBond haemostatic agentOTHER

Application of Purabond to surgical field

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Purabond not applied
  • incomplete case notes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Birmingham NHS Trust

Birmingham, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Keshav Gupta, MBBS

    ENT registrar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ENT Registrar

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 6, 2022

Study Start

August 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations

GB(1)