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 in efficacy to the common practice of CSD insertion by wound closure, measured…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome of efficacy is measured by the derivative outcome of wound
complications like haematoma, haemorrhage, wound infection, seroma, dehiscence,
skin necrosis.
Secondary outcome
Secondary parameters include facial nerve function and more tardy complications
like fistula, sialocele and Frey*s syndrome. Additionally, patient satisfaction
(measured by short survey), duration of hospital admission and the need for
re-admission will be recorded.
Background summary
Parotid gland surgery is the designated treatment for a tumor of the parotid
gland, whether benign or malignant. The extent of the procedure is based on
localization and histology. Most common a superficial parotidectomy is
performed. Deep gland or malignant tumors require a more extensive procedure,
involving the removal of the total gland, potentially combined with dissection
of the lymph nodes of the neck. Risk of facial nerve dysfunction depends mainly
on the dimension of chosen surgery, other complications are more widely seen in
all types of parotidectomy. Those range from wound complication - including
haematoma, haemorrhage, infection, dehiscence and necrosis - till complications
resulting from anatomical changes like sialoceles or fistulas, Frey*s syndrome
and from greater auricular nerve (GAN) dissection. In order to keep
postoperative fluid collections of blood, lymph and saliva restricted to a
minimum in the surgical area, current common practice dictates the insertion of
a closed suction drain (CSD) before closure.
Study 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 in efficacy to the common practice of CSD insertion by wound
closure, measured by post-operative wound complications. 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.
Study design
Patients undergoing parotid gland surgery and participating in this study will
undergo the standard parotid surgery intended for their tumor, including the
additional application of TachoSil to the surgical field. After this
application no CSD will be placed. This will enable to perform the surgery
under day care/short stay conditions. Postoperatively, the amount of
complications will be recorded prospectively, together with the duration of
hospital admission and the eventual need for re-admission.
Intervention
Application of TachoSil to the wound, after which no CSD will be placed.
Study burden and risks
Potential disadvantage for the patient is the risk of hypersensitivity
reactions in case of allergy for human blood products or horse protein.
Patients will be asked for a history of allergy, especially related to these
products. A possible reaction is expected to occur within minutes till hours
after surgery. At this moment, patients will be still in hospital so could
directly receive specialized medical care conform current medical guidelines
for allergy or shock.
Ultimately, this could result in opening of the wound and removal of TachoSil
in case of a life threatening reaction.
Other problems could result out of the lack of CSD by not well-applied or
well-functioning TachoSil. Leaking blood, lymph and/or saliva could form a
fluid collection. Large collections will dictated the need of puncture by
needle or even opening the wound and placing an CSD.
The application of TachoSil itself during surgery wil form no extra burden for
participants.
Yet, participants will enjoy the expected benefits of the lack of wound drain
and the use of TachoSil:
• No drain; this means no inconvenience of this drain and no possibility of
infection through the drain.
• Day surgery; same day hospital admission and discharge so recovery in
patients own environment.
• Significantly lower healthcare costs as result of shorter hospital admission.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
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, when treatment with sole parotidectomy will be sufficient (i.e. no extensive surgery or adjuvant radiotherapy).
• Patients older than 18 years, there is no upper age limit.
• Signed informed consent is required.
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 necessity of adjuvant radiotherapy (e.g. in case of malignancy of tumor spill).
• Known allergy for the product of TachoSil or its substances like for human blood products or horse protein.
• Known immunodeficiency, because of increased risk by transmitted viral agents.
• Anamnestic presence of pregnancy or nursery giving.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-005653-22-NL |
| CCMO | NL42707.031.14 |