TissuePAtchDS-P ™ PArotidectomy Trial (TAPAS)
Research type
Research Study
Full 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.
IRAS ID
248482
Contact name
Emma King
Contact email
Sponsor organisation
Poole Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
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.
Summary of Results
Link: https://onlinelibrary.wiley.com/doi/10.1111/coa.13594
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/1505
Date of REC Opinion
3 Dec 2018
REC opinion
Further Information Favourable Opinion