The surgical procedure of parotidectomy whereby a protid tumor is removed. During this procedure the wound surface will be covered by the surgical sealing patch TachoSil instead of the use of a closed suction drain.
Conditions
Interventions
Trade Name: TachoSil
Product Name: TachoSil
Pharmaceutical Form: Medicated sponge
Sponsors
Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
Takeda Nederland B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing surgery for a parotid gland tumor. • Indications for parotidectomy are - fine needle aspiration cytology (FNAC) proven benign or malignant parotid tumors - Persistent clinical suspicion of a parotid tumor despite negative FNAC. • For this prospective study patients undergoing all forms of parotid surgery are eligible. • Patients with benign as well as malignant parotid tumors are eligible, even when the latter is a metastasis from another malignant primary tumor. • There is no age limit. • Signed informed consent is required. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 112 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting (one of) the following criteria are excluded from participation in this study: • Pre-existing coagulation disorders (anticoagulant therapy must be on pause, continuing use of acetylsalicylic acid is permitted) • History of surgery, radiation or open trauma to the ipsilateral neck or parotid area • Receiving concurrent neck dissection because of the extent of the surgical field • Known allergy for the product of TachoSil or its substances like for human blood products or horse protein. • Anamnestic presence of pregnancy or nursery giving.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary parameters include facial nerve function and more tardy complications like fistula, sialocele and Frey's syndrome. Additionally, patient satisfaction (measured by short questionnaire), duration of hospital admission and the need for re-admission will be recorded.;Timepoint(s) of evaluation of this end point: After the inclusion and follow-up of 112 consecutive patients, the results of these patients will be compared with the retrospective cohort of 400 patient who are treated by parotidectomy the last 10 year.;Main Objective: The primary objective of the study is to provide evidence that the use of a sealing surgical patch applied to the surgical field following parotidectomy is non-inferior (according to preset limits) to the common practice of CSD insertion by wound closure, measured by post-operative wound complications (haematoma, haemorrhage, wound infection, seroma, dehiscence, skin necrosis). If so, TachoSil will be able to replace CSD because it is much more convenient for patients than a CSD. It means no irritation of the drain, no potential infection route and no need for specialized care in the hospital so more early discharge and resulting in recovery in the own home environment.;Primary end point(s): The primary endpoint is the percent of patients who developed a wound complication after the intervention. Parotidectomy including additional application of the TachoSil patch instead of closed suction drainge is thought to result in a wound complication rate that is not inferior (according to preset limits) compared to the standard procedure of closed suction drainage without TachoSil. The number of wound complications will be recorded prospectively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint include facial nerve function and more tardy complications like fistula, sialocele and Frey's syndrome. Additionally, patient satisfaction will be measured by short survey. These endpoints will only be discribed because of these parameters are not welldocumented in the retrospective cohort. However, duration of hospital admission and the need for re-admission will be recorded and tried to be compared to the retrospective cohort.;Timepoint(s) of evaluation of this end point: After the inclusion and follow-up of 112 consecutive patients, the results of these patients - if possible - will be compared with the retrospective cohort of 400 patient who are treated by parotidectomy the last 10 year. | — |
Countries
Netherlands
Contacts
Public ContactA.J.M. Balm
Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
Outcome results
None listed