TissuePAtchDS--P ™ PArotidectomy Trial.
- Conditions
- Parotid Gland Disorders
- Interventions
- Device: TissuePatchDS-P™Device: Surgical Drain
- Registration Number
- NCT04116762
- Lead Sponsor
- Poole Hospital NHS Foundation Trust
- 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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- All patients undergoing superficial parotidectomy for benign parotid disease.
- Patients 18 years of age or above.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention TissuePatchDS-P™ Placement of TissuePatchDS-P™ at time of operation. No surgical drain is used. Control Surgical Drain No use of TissuePatchDS-P™. Wound is closed with a surgical drain (Surgeon's choice) in situ.
- Primary Outcome Measures
Name Time Method Proportion of participants discharged at day 0 following superficial parotidectomy. Day one
- Secondary Outcome Measures
Name Time Method Number of complications Three months Number of complications (e.g. haematoma, seroma, salivary fistula and symptomatic Frey's syndrome)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN35) Three months
Trial Locations
- Locations (1)
Poole Hospital NHSFT
🇬🇧Poole, Dorset, United Kingdom