Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Odense University Hospital
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Number of participants with seroma
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Negative pressure wound therapy
Intervention: Negative pressure wound therapy (Device)
Control
Micropore tape
Intervention: Micropore tape (Other)
Outcomes
Primary Outcomes
Number of participants with seroma
Time Frame: 3 months
One or more inguinal seroma(s) which require aspiration
Secondary Outcomes
- Number of participants with wound rupture(3 months)
- Questionnaire EQ-5D-5L(Baseline, 3 months and 2 years)
- Number of participants with lymphedema(2 years)
- Number of participants with regional recurrence(2 years)
- Number of seromas for each participant(3 months)
- Number of participants with surgical wound infection(3 months)
- Number of participants with wound necrosis(3 months)
- Hospitalization readmission time(3 months)
- Questionnaire LYMQOL(2 years)
- Volume of seromas for each participant(3 months)
- Number of participants with hematoma(3 months)
- Hospitalization time(3 months)
- Number of participants with reoperations(3 months)
Investigators
Mads Gustaf Jørgensen
MD
Odense University Hospital