Lymphedema, Quality of Life, Seroma, Surgical Site Infection
Conditions
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.
Interventions
DEVICENegative pressure wound therapy
Wound dressing
OTHERMicropore tape
Wound dressing
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with seroma | 3 months | One or more inguinal seroma(s) which require aspiration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of seromas for each participant | 3 months | Volume of aspirated seromas (mL) |
| Number of participants with surgical wound infection | 3 months | Inguinal wound infection which require antibiotic treatment |
| Number of participants with wound rupture | 3 months | Inguinal wound rupture which require addition suturing or NPWT treatment |
| Number of participants with wound necrosis | 3 months | Inguinal wound necrosis which require debridement |
| Number of participants with hematoma | 3 months | Inguinal wound hematoma which require evacuation |
| Questionnaire EQ-5D-5L | Baseline, 3 months and 2 years | Quality of life measurement score |
| Number of seromas for each participant | 3 months | Number of aspirated seromas (No.) |
| Hospitalization readmission time | 3 months | Length of hospital readmissions (days) |
| Number of participants with reoperations | 3 months | Re-operation with opening of the wound or scar under general anesthesia due to adverse complications |
| Number of participants with lymphedema | 2 years | Clinical evaluation using the International Lymphedema Society staging |
| Questionnaire LYMQOL | 2 years | Lymphedema quality of life measurement score |
| Number of participants with regional recurrence | 2 years | Histological verified recurrence to the inguinal site |
| Hospitalization time | 3 months | Length of hospital stay until discharge (days) |
Countries
Denmark
Outcome results
None listed