Short summary

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

Rationale

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.

Collaborating researchers and departments

Odense University Hospital

• Mads G Jørgensen, PhD-student
• Nana Hyldig, MHSc, PhD, Postdoc
• Jørn B Thomsen, MD, PhD
• Jens A Sørensen, MD, PhD

• Lisbet R Hölmich, MD, DMSc
• Annette H Chakera, MD, PhD

• Jørgen L Andersen, MD, DMSc
• Navid M Toyserkani, MD