The effect of ARTISS on latissimus dorsi donor site seroma formation after breast reconstruction: a randomised controlled trial.

INTERVENTION: Trade Name: ARTISS Product Name: ARTISS Pharmaceutical Form: Suspension and solution for spray CONDITION: 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. Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] SECONDARY OUTCOME: 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. 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 PRIMARY OUTCOME: 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. 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 complications will be taken into account. That is, the total volume of drainage during hospitalization, duration of drainage, donor‐site pain, length of stay in the hospital, and costs. 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. Timepoint(s) of evaluation of this end point: During hospitalization drainage volumes will be measured starting on day one. The duration of drainage will be recorded (i.e., in days). When the drains are removed (<50cc/24h), the patient does not have fever or pain (VAS score = 2), and no signs of an infection, 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. It will also be evaluated how many times the seroma has to be punctuated (when the patient reports discomfort caused by seroma or if the size of the seroma is = 20mL, diagnosed with clinical examination and/ or by ultrasound).