The aim of this study is to investigate the effect of the fibrin sealant ARTISS compared with our standard care on total volume of donor site seroma after harvesting a LD in immediate breast reconstruction. Our secondary outcomes are drainage volume and duration of drainage, length of hospital stay of a patient, other postoperative complications besides donor site seroma (such as infection), pain measured by the Visual Analog Scale (VAS), and costs in euros.
Conditions
Interventions
Trade Name: ARTISS
Product Name: ARTISS
Pharmaceutical Form: Suspension and solution for spray
Sponsors
Isala Klinieken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All female patients older than 18 years, who will undergo a breast reconstruction with a LD flap will be included. All participating patients have to sign a written consent, before they can be included in our study. 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 118 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who are pregnant, have a pre-operative on-going infection, history of systemic anti-coagulant use, known hypersensitivity to ARTISS or postoperative haemorrhage will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to investigate the effect of ARTISS compared with our standard care on total volume of donor site seroma after harvesting a LD in breast reconstruction.;Secondary Objective: Our secondary outcomes are drainage volume and duration of drainage, length of hospital stay of a patient, other postoperative complications besides donor site seroma (such as infection), pain measured by the Visual Analog Scale (VAS), and costs in euros. ;Primary end point(s): The aim of this study is to investigate the effect of ARTISS compared with conventional care (i.e., only vacuum drains after wound closure) on the formation of total volume of donor site seroma after harvesting a LD for breast reconstruction. Seroma is diagnosed, when = 20 mL can be aspirated after fine needle aspiration or diagnosed with ultrasound after removal of all drains. During hospitalization drainage volumes will be measured starting on day one. The drains will be removed if measured output is less than 50 mL per 24h. The duration of drainage will be recorded (i.e., in days). When the drains are removed and when the patient does not have fever, no drains, no severe pain (VAS score = 4), no signs of an infection, and when the patient can manage daily activities, the patient can be discharged. Clinical examination will be performed at one, two, six, and twelve weeks after discharge. Evidently, when the patient reports discomfort caused by seroma in-between the standard moments afore-mentioned, he or she will visit the hospital and these visits will also be counted. Also the amount of punctation of seroma will be analysed. An aspiration of the seroma is neccesary when a patient reports discomfort caused by seroma or if the size of the seroma is = 20mL, diagnosed with clinical examination and/ or by ultrasound seroma is aspirated. Otherwise, seroma-related complication can occur, such as infection or necrosis of the skin. In addition to the formation of seroma, other complica | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes include total drainage volume, duration of drainage, pain, length of stay in the hospital, and costs.;Timepoint(s) of evaluation of this end point: The same timepoints as afore-mentioned. | — |
Countries
Netherlands
Contacts
Public ContactZwols Wetenschapsfonds Isala Klinie
ZWIK
Outcome results
None listed