Head and Neck CancerROUNDNCT06178237
RADA16 for Reducing Drain Output Trajectory Following Neck Dissection
A study testing Purabond in people with Head and Neck Cancer, run by St. James's Hospital, Ireland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Purabond
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients unable to satisfy all the above listed inclusion criteria.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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).
- Conditions
- Head and Neck Cancer
- Being tested
- Purabond
- Keywords
- seroma
- Medical subject headings
- Head and Neck Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PurabondDevice
Also called RADA16
Application of Purabond to surgical field
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Standard of care post-neck dissection |
| Standard of care plus Purabond | Experimental | Standard of care post-neck dissection plus Purabond Receives: Device: Purabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of fluid drained
Total output from intraoperatively placed drain plus any additional drainage performed percutaneously
Measured: 3 months
Duration of drain placement
Duration of drain placement
Measured: Until drain removal, usually within 2 weeks
Secondary outcomes (4)
Haematoma
Haematoma
Measured: Usually within 1 week
Number of percutaneous aspirations required
Number of percutaneous aspirations required
Measured: 3 months
Duration of inpatient stay
Duration of inpatient stay
Measured: 3 months
Number of patients with neck dissection complications relevant to drains management
Complications affecting drain management - chyle leak, pharyngocutaenous fistula, anastomotic leak
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study startMar 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Responsible party
- Principal investigator, Gerard Sexton, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178237
- Sponsor's protocol ID
- 000117
- Acronym
- ROUND
- Status last verified
- Dec 2023
- First submitted
- 31 Oct 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADA16 for Reducing Drain Output Trajectory Following Neck Dissection
- ClinicalTrials.gov ID
- NCT06178237
- Acronym / sponsor ID
- ROUND / 000117
- Conditions
- Head and Neck Cancer
- Keywords
- seroma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Standard of care post-neck dissection |
| Standard of care plus Purabond | Experimental | Device: PurabondStandard of care post-neck dissection plus Purabond |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients unable to satisfy all the above listed inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PurabondAlso: RADA16Application of Purabond to surgical field | Device | Standard of care plus Purabond |
Primary outcome
Total volume of fluid drained
Time frame: 3 months
Total output from intraoperatively placed drain plus any additional drainage performed percutaneously
Duration of drain placement
Time frame: Until drain removal, usually within 2 weeks
Duration of drain placement
4 secondary outcomes
Haematoma
Time frame: Usually within 1 week
Number of percutaneous aspirations required
Time frame: 3 months
Duration of inpatient stay
Time frame: 3 months
Number of patients with neck dissection complications relevant to drains management
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Purabond in people with Head and Neck Cancer, run by St. James's Hospital, Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerard Sexton (014103000, gerardsexton@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume of fluid drained (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.