TissuePAtchDS--P ™ PArotidectomy Trial.

NCT04116762 | Terminated

• 1 other identifier: SP170310A
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Parotid Gland Disorders

Outcome Measures

Primary Outcomes (1)

• Proportion of participants discharged at day 0 following superficial parotidectomy.

  Day one

Secondary Outcomes (2)

• Number of complications

  Three months

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN35)

  Three months

Study Arms (2)

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

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

Intervention

Surgical Drain DEVICE

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poole Hospital NHS Foundation Trust: lead

Study Sites (1)

Poole Hospital NHSFT

Poole, Dorset, BH15 2JB, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: November 30, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)