Parotid Gland Disorders Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03172520 -
Automatic Periodic Stimulation and Continuous Electromyography (EMG) for Facial Nerve Monitoring During Parotidectomy
|
N/A |