(wound) fluid collection Seroma
Conditions
Interventions
Firstly, the general surgeon will perform a mastectomy. One drain will be
inserted in the cavity of the amputated breast. Hereafter, the LD flap is
harvested by a qualified plastic surgeon using the
latissimus dorsi
Seroma
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 64 Years
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.
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 |
|---|---|
| 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 immediate breast reconstruction. 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, pain (VAS score = 20mL, diagnosed with clinical examination and/ or by ultrasound). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
The Netherlands
Outcome results
None listed