RADA16 for Reducing Drain Output Trajectory Following Neck Dissection (ROUND)

December 11, 2023 updated by: Gerard Sexton, St. James's Hospital, Ireland
This will be a prospective single-blind randomised controlled trial to evaluate if the use of a medical device named Purabond, a haemostatic agent already CE marked for use in Ireland, can reduce the occurrence of seroma, a complication related to but distinct from haematoma, following neck dissection surgery. Patients undergoing neck dissection surgery will be randomised either to standard post-operative care following neck dissection or to standard post-operative care and Purabond. Drains are placed routinely following surgery of this type and their removal is dictated by the volume of fluid produced per day - it is hypothesised that Purabond will reduce the volume of fluid produced and thereby facilitate earlier drain removal.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purabond is a new medical device taking the form of a gel containing an active ingredient called RADA-16. It is designed to stop bleeding from wounds by forming into a stable barrier (matrix) when coming into contact with ionic fluids like blood. Purabond is already currently use for procedures by Cardiology, General Surgery, Vascular, Gynaecology, and ENT. Specific uses in ENT surgery so far have been for sinus surgery. Purabond is CE marked and indicated for situations where haemostasis by standard means is insufficient or impractical.

The investigators hypothesise that Purabond will reduce the duration for which neck drains must be left in place after neck dissection, which is an operation to remove lymph nodes from the neck. Following neck dissection, fluid can leak into the healing tissues in the neck from very small damaged blood vessels - when an excess of this fluid builds up underneath the skin this is called a seroma. This occurs in 1.3-7% of patients and represents a potential area for infection as well as a noticeable lump. Readmission is sometimes required in the event of an infected seroma though there is no published evidence on how common this is. Drains are placed during neck dissection surgery to remove this fluid and to also reduce the overall seroma rate. Drains are left in until the volume of fluid being produced decreases. The duration for which drains are left in place is also affected by the development of other, rarer complications - specifically chyle leak, anastomotic leak, and pharyngocutaneous fistula. In the setting of any of the above, drains are often left in for longer to ensure any fluid that accumulates is removed and that dead space in the neck is kept to a minimum.

This study aims to assess if Purabond can speed up the process of removing drains. The fluid that makes up a seroma leaks out from damaged blood vessels in the same way a haematoma (collection of blood in the neck) does but the vessels of interest in a seroma are smaller and more numerous - manual ligation of these is not feasible. As Purabond forms a matrix in response to ionic fluids (including seroma) it is expected to reduce the rate of seroma by sealing such vessels. The benefits of this would be reduced duration of stay in hospital for patients with otherwise uncomplicated neck dissections but also reducing infection risk to patients with more complex needs who could otherwise have their drains removed earlier. It would also be expected to reduce the subsequent need for readmission and aspiration of seroma. These findings would then be more broadly applicable to less extensive neck surgeries where there is a risk of seroma but drains are not placed frequently (parotidectomy, thyroidectomy, etc).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with head and neck cancer (including thyroid, cutaneous, & mucosal primaries) for which a neck dissection is indicated as part of treatment.
  • Over 18 years of age.
  • Able to give informed consent.

Exclusion Criteria:

  • Patients unable to satisfy all the above listed inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of care
Standard of care post-neck dissection
Experimental: Standard of care plus Purabond
Standard of care post-neck dissection plus Purabond
Device: Purabond
Application of Purabond to surgical field
Other Names:
  • RADA16

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total volume of fluid drained
Time Frame: 3 months
Total output from intraoperatively placed drain plus any additional drainage performed percutaneously
3 months
Duration of drain placement
Time Frame: Until drain removal, usually within 2 weeks
Duration of drain placement
Until drain removal, usually within 2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Haematoma
Time Frame: Usually within 1 week
Haematoma
Usually within 1 week
Number of percutaneous aspirations required
Time Frame: 3 months
Number of percutaneous aspirations required
3 months
Duration of inpatient stay
Time Frame: 3 months
Duration of inpatient stay
3 months
Number of patients with neck dissection complications relevant to drains management
Time Frame: 3 months
Complications affecting drain management - chyle leak, pharyngocutaenous fistula, anastomotic leak
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. James's Hospital, Ireland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Royal College of Surgeons, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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