PhD student Mads Gustaf Jørgensen Department of Plastic Surgery, Odense University Hospital
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere
Inkluderet antal deltagere
Inkluderede deltagere med prøver
Prevention of seroma following inguinal lymph node dissection with Incisional Negative Pressure Wound Therapy: A randomized controlled open-labelled multicenter trial
Lymphadenectomy is indicated following metastatic malignant melanoma, and is associated with a high-complication rate, of which many begin with the formation of seroma and ends in complicated wound healing, reoperation, multiple outpatient visits and re-hospitalization.Prevention of seroma, can therefore lead to a reduction in many of the preceding complications
In smaller trials, Incisional negative pressure therapy has so far shown great potential in seroma prevention. The primary aim of this randomized study is to investigate whether the number of malignant melanoma patients with treatment necessitating seroma can be halved, by the immediate prophylactic application of iNPWT following inguinal lymphadenectomy. The secondary outcomes include wound infection, dehiscence, hematoma, hospitalization time, quality of life, costs, and long term assessment of lymphedema and non-inferiority oncological outcome.
Description of the cohort
All MM patients who are candidates for inguinal lymph node dissection and 18 years of age or older, will be approached for inclusion. Patients will be randomized into one of two groups. One group are treated with the standard postoperative wound dressing, and one group are treated with iNPWT over the inguinal wound for the first two weeks.
Data and biological material
The primary outcome is the number of patients with aspiration necessitating seroma. Secondary outcomes includes wound infection, hematoma, hospitalization, reoperations, HR-QoL (EQ5D-5L), wound exudates, dehiscence and necrosis. In the long term, lymphedema and locoregional recurrences are assessed aswell.