TissuePAtchDS--P ™ PArotidectomy Trial. | NCT04116762

Studies
TissuePAtchDS--P ™ PArotidectomy Trial.

NCT04116762

Sponsor

Poole Hospital NHS Foundation Trust

Status

Terminated

Last Update Posted

Oct 16, 2019Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Parotid Gland Disorders

Interventions

TissuePatchDS-P™
Surgical Drain

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

All 3 participants receiving intervention in assessment phase developed seromas

Expanded Access Info

Start Date

Nov 30, 2018Actual

Primary Completion Date

Oct 1, 2019Actual

Completion Date

Oct 1, 2019Actual

First Submitted Date

Oct 3, 2019

First Submission Date that Met QC Criteria

Oct 3, 2019

First Posted Date

Oct 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2019

Last Update Posted Date

Oct 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Placement of TissuePatchDS-P™ at time of operation. No surgical drain is used.	Device: TissuePatchDS-P™
Control	Active Comparator	No use of TissuePatchDS-P™. Wound is closed with a surgical drain (Surgeon's choice) in situ.	Device: Surgical Drain

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of participants discharged at day 0 following superficial parotidectomy.		Day one

Secondary Outcomes

Measure	Description	Time Frame
Number of complications	Number of complications (e.g. haematoma, seroma, salivary fistula and symptomatic Frey's syndrome)	Three months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN35)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients undergoing superficial parotidectomy for benign parotid disease.
Patients 18 years of age or above.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Poole Hospital NHSFT		Poole	Dorset	BH15 2JB	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jul 30, 2020
Reset	Aug 13, 2020
Release	Aug 14, 2020
Reset	Aug 14, 2020

Submission Tracking

Estimated Results First Submitted Date

Jul 30, 2020

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 30, 2020			Aug 13, 2020
Aug 14, 2020

Intervention Model Description

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.
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).