Parotid Gland DisordersTAPASNCT04116762
TissuePAtchDS--P ™ PArotidectomy Trial.
A study testing TissuePatchDS-P™ and Surgical Drain in people with Parotid Gland Disorders, run by Poole Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The parotid (salivary) gland can develop growths (tumours), most of which are not cancerous but may develop into a cancer if left untreated. Tumours located near the surface of the gland are surgically removed in a procedure called a superficial parotidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotid Gland Disorders
- What is being tested?
- TissuePatchDS-P™ and Surgical Drain
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Nov 2018to 1 Oct 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing superficial parotidectomy for benign parotid disease.
- Patients 18 years of age or above.
Who cannot join
- American Society of Anesthesiologists (ASA) classification >2 and/or Body Mass Index (BMI) >35.
- Any patient with malignant, infected/inflamed or recurrent parotid disease.
- Patients taking immunosuppressants.
- Patients with a history of allergic reaction to the composites of the patch
- Previous parotid surgery to the same side.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Use of TissuePAtchDS-P Allow for Day Case PArotid Surgery? A Randomised Controlled Superiority Trial Comparing TissuePatchDS-P Versus Surgical Drain in Benign Superficial Parotidectomy.
The parotid (salivary) gland can develop growths (tumours), most of which are not cancerous but may develop into a cancer if left untreated. Tumours located near the surface of the gland are surgically removed in a procedure called a superficial parotidectomy. Post-surgery, fluid accumulates in the space left behind by the gland and currently, this is managed via insertion of a surgical drain (tube attached to a vacuumed bottle). Patients are then routinely admitted to hospital for 24-48 hours until it is safe for the drain to be removed.
As well as the need for a prolonged hospital stay, there are known risks associated with drains e.g. infection, fluid collection under the skin (seroma) and communication between parotid tissue and the skin (fistula). This study aims to evaluate the effectiveness of applying an adhesive sealant (TissuePatchDS-P) between the parotid gland and the skin after removal of a non-cancerous parotid tumour. This would be instead of a surgical drain, as the sealant closes the space and should prevent fluid build-up. This may allow for same-day discharge and reduce complications.
Read the detailed description
The parotid (salivary) gland can develop growths (tumours), most of which are not cancerous but may develop into a cancer if left untreated. Tumours located near the surface of the gland are surgically removed in a procedure called a superficial parotidectomy. Post-surgery, fluid accumulates in the space left behind by the gland and currently, this is managed via insertion of a surgical drain (tube attached to a vacuumed bottle). Patients are then routinely admitted to hospital for 24-48 hours until it is safe for the drain to be removed.
As well as the need for a prolonged hospital stay, there are known risks associated with drains e.g. infection, fluid collection under the skin (seroma) and communication between parotid tissue and the skin (fistula). This study aims to evaluate the effectiveness of applying an adhesive sealant (TissuePatchDS-P) between the parotid gland and the skin after removal of a non-cancerous parotid tumour. This would be instead of a surgical drain, as the sealant closes the space and should prevent fluid build-up. This may allow for same-day discharge and reduce complications.
As no trials to date have used TissuePatchDS-P without a surgical drain, this study will run in two phases - an assessment/pilot phase with 5 participants using TissuePatchDS-P only. This will include compulsory overnight stay and ultrasound scan within 24 hours to ensure safety before progressing to the randomised controlled trial phase. In this phase, 50 participants will be randomised to receive either: surgical drain (standard care) or TissuePatchDS-P. After surgery, patients in both groups will be reviewed by their care team and discharged when appropriate.
Participants will be followed up at their routine 6-week post-surgical visit and then a trial doctor will conduct a study-related telephone consultation at 3 months post-surgery for long-term assessment of safety, clinical outcomes and quality of life.
- Conditions
- Parotid Gland Disorders
- Being tested
- TissuePatchDS-P™, Surgical Drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TissuePatchDS-P™Device
The therapy to be used in the intervention arm is TissuePatchDS-P™. This is a preformed, standard-sized artificial adhesive that will be used between the parotid tissue and subcutaneous tissue. It can be cut to an appropriate size for the defect. The intention of this installation is to seal and close the potential space that is created with removal of superficial parotid tissue
Surgical DrainDevice
A surgical drain used in superficial parotid surgery is a thin polyvinylchloride (PVC) tube, with perforations at the end, which is placed at the end of the procedure before the surgical wound is closed in the cavity created following removal of parotid tissue. The tube is connected to a closed vacuum system attached to a plastic bottle outside of the patient's body which acts to remove the fluid that collects after an operation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Placement of TissuePatchDS-P™ at time of operation. No surgical drain is used. Receives: Device: TissuePatchDS-P™ |
| Control | Active comparator | No use of TissuePatchDS-P™. Wound is closed with a surgical drain (Surgeon's choice) in situ. Receives: Device: Surgical Drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants discharged at day 0 following superficial parotidectomy.
Measured: Day one
Secondary outcomes (2)
Number of complications
Number of complications (e.g. haematoma, seroma, salivary fistula and symptomatic Frey's syndrome)
Measured: Three months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN35)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start30 Nov 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: All 3 participants receiving intervention in assessment phase developed seromas
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parotid Gland DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. The first part is to perform a pilot study at the lead site only, which will recruit 5 patients to have their surgery using TissuePatchDS-P alone to ensure that the product is safe to use and that no immediate complications are observed. 2. If the pilot data suggests that TissuePatch is not associated with immediate, short or medium term complications (as confirmed by the investigators, sponsor and independent Trial Steering Committee) the trial will progress to the randomised controlled phase. A total of 50 patients will be recruited from the outpatient setting at participating National Health Service (NHS) trusts - 25 will be randomised to the control group (surgical drain) and 25 will be randomised to the intervention arm (TissuePatch).
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poole Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116762
- Sponsor's protocol ID
- SP170310A
- Acronym
- TAPAS
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of TissuePAtchDS-P Allow for Day Case PArotid Surgery? A Randomised Controlled Superiority Trial Comparing TissuePatchDS-P Versus Surgical Drain in Benign Superficial Parotidectomy.
- ClinicalTrials.gov ID
- NCT04116762
- Acronym / sponsor ID
- TAPAS / SP170310A
- Conditions
- Parotid Gland Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All 3 participants receiving intervention in assessment phase developed seromas
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Poole Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 7 Oct 2019 (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.
The parotid (salivary) gland can develop growths (tumours), most of which are not cancerous but may develop into a cancer if left untreated. Tumours located near the surface of the gland are surgically removed in a procedure called a superficial parotidectomy. Post-surgery, fluid accumulates in the space left behind by the gland and currently, this is managed via insertion of a surgical drain (tube attached to a vacuumed bottle). Patients are then routinely admitted to hospital for 24-48 hours until it is safe for the drain to be removed.
As well as the need for a prolonged hospital stay, there are known risks associated with drains e.g. infection, fluid collection under the skin (seroma) and communication between parotid tissue and the skin (fistula). This study aims to evaluate the effectiveness of applying an adhesive sealant (TissuePatchDS-P) between the parotid gland and the skin after removal of a non-cancerous parotid tumour. This would be instead of a surgical drain, as the sealant closes the space and should prevent fluid build-up. This may allow for same-day discharge and reduce complications.
Detailed description
The parotid (salivary) gland can develop growths (tumours), most of which are not cancerous but may develop into a cancer if left untreated. Tumours located near the surface of the gland are surgically removed in a procedure called a superficial parotidectomy. Post-surgery, fluid accumulates in the space left behind by the gland and currently, this is managed via insertion of a surgical drain (tube attached to a vacuumed bottle). Patients are then routinely admitted to hospital for 24-48 hours until it is safe for the drain to be removed.
As well as the need for a prolonged hospital stay, there are known risks associated with drains e.g. infection, fluid collection under the skin (seroma) and communication between parotid tissue and the skin (fistula). This study aims to evaluate the effectiveness of applying an adhesive sealant (TissuePatchDS-P) between the parotid gland and the skin after removal of a non-cancerous parotid tumour. This would be instead of a surgical drain, as the sealant closes the space and should prevent fluid build-up. This may allow for same-day discharge and reduce complications.
As no trials to date have used TissuePatchDS-P without a surgical drain, this study will run in two phases - an assessment/pilot phase with 5 participants using TissuePatchDS-P only. This will include compulsory overnight stay and ultrasound scan within 24 hours to ensure safety before progressing to the randomised controlled trial phase. In this phase, 50 participants will be randomised to receive either: surgical drain (standard care) or TissuePatchDS-P. After surgery, patients in both groups will be reviewed by their care team and discharged when appropriate.
Participants will be followed up at their routine 6-week post-surgical visit and then a trial doctor will conduct a study-related telephone consultation at 3 months post-surgery for long-term assessment of safety, clinical outcomes and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. The first part is to perform a pilot study at the lead site only, which will recruit 5 patients to have their surgery using TissuePatchDS-P alone to ensure that the product is safe to use and that no immediate complications are observed. 2. If the pilot data suggests that TissuePatch is not associated with immediate, short or medium term complications (as confirmed by the investigators, sponsor and independent Trial Steering Committee) the trial will progress to the randomised controlled phase. A total of 50 patients will be recruited from the outpatient setting at participating National Health Service (NHS) trusts - 25 will be randomised to the control group (surgical drain) and 25 will be randomised to the intervention arm (TissuePatch).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: TissuePatchDS-P™Placement of TissuePatchDS-P™ at time of operation. No surgical drain is used. |
| Control | Active comparator | Device: Surgical DrainNo use of TissuePatchDS-P™. Wound is closed with a surgical drain (Surgeon's choice) in situ. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing superficial parotidectomy for benign parotid disease.
- Patients 18 years of age or above.
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) classification >2 and/or Body Mass Index (BMI) >35.
- Any patient with malignant, infected/inflamed or recurrent parotid disease.
- Patients taking immunosuppressants.
- Patients with a history of allergic reaction to the composites of the patch
- Previous parotid surgery to the same side.
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 |
|---|---|---|
| TissuePatchDS-P™The therapy to be used in the intervention arm is TissuePatchDS-P™. This is a preformed, standard-sized artificial adhesive that will be used between the parotid tissue and subcutaneous tissue. It can be cut to an appropriate size for the defect. The intention of this installation is to seal and close the potential space that is created with removal of superficial parotid tissue | Device | Intervention |
| Surgical DrainA surgical drain used in superficial parotid surgery is a thin polyvinylchloride (PVC) tube, with perforations at the end, which is placed at the end of the procedure before the surgical wound is closed in the cavity created following removal of parotid tissue. The tube is connected to a closed vacuum system attached to a plastic bottle outside of the patient's body which acts to remove the fluid that collects after an operation. | Device | Control |
Primary outcome
Proportion of participants discharged at day 0 following superficial parotidectomy.
Time frame: Day one
2 secondary outcomes
Number of complications
Time frame: Three months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN35)
Time frame: Three months
Results and safety
The study was stopped early (reason given: All 3 participants receiving intervention in assessment phase developed seromas). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Parotid Gland Disorders
RecruitingPhase 1/2
Study of Circular RNA Treatment in Patients With Radiation Induced Xerostomia-1
Radiation-Induced Xerostomia and Hyposalivation
Active, not recruitingPhase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm
RecruitingPhase 4
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Heart Transplant Infection Prevention
RecruitingEarly Phase 1
Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor
Parotid Neoplasm, Bupivacaine
Not yet recruitingPhase 3
A Study on the Immune Response and Safety of an Investigational Combined Measles, Mumps, Rubella and Varicella Vaccine, When Given to Healthy Children 4 to 6 Years of Age
Measles, Mumps
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TissuePatchDS-P™ and Surgical Drain in people with Parotid Gland Disorders, run by Poole Hospital NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: All 3 participants receiving intervention in assessment phase developed seromas). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants discharged at day 0 following superficial parotidectomy. (time frame: Day one). 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 16 Oct 2019.