TerminatedNot Applicable

Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy

Stopped: Low inclusion

Denmark20 participantsStarted 2018-04-01

Plain-language summary

Inguinal lymph node dissection (ILND) 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 may therefore lead to a reduction of many of the preceding complications and improve patient quality-of-life. The aim of this study is to evaluate the efficacy and oncological safety of prophylactic negative pressure wound therapy following ILND in melanoma patients.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * All malignant melanoma patients who are candidates for ILND and 18 years of age or older Exclusion Criteria: * Patients suspected of having tumor residuals after ILND, previous groin irradiation or patients suffering from dementia or any psychiatric disorder making them incapable of informed consent or adherence to follow up, along with patients who are unable to communicate in Danish or English will not be included in the study.

What they're measuring

Number of participants with seroma

Timeframe: 3 months

Trial details

NCT IDNCT03433937

SponsorOdense University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-01

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