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TissuePAtchDS--P ™ PArotidectomy Trial.

NCT04116762 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-10-16

No results posted yet for this study

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

Interventions

DEVICE

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

Surgical Drain

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.

Sponsors & Collaborators

  • Poole Hospital NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2019-10-01
Completion
2019-10-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04116762 on ClinicalTrials.gov