Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178237
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-10-31
Brief Title:
RADA16 for Reducing Drain Output Trajectory Following Neck Dissection
Sponsor:
St Jamess Hospital Ireland
Organization:
St Jamess Hospital Ireland
Study Overview
Official Title:
RADA16 for Reducing Drain Output Trajectory Following Neck Dissection
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROUND
Brief 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 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 13-7 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
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 13-7 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None