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

Study Overview
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Brief Summary
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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.

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

Conditions
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Seroma, Surgical Site Infection, Lymphedema, Quality of Life

Intervention / Treatment
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* Device: Negative pressure wound therapy
* Other: Micropore tape


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Negative pressure wound therapy<br> | Device: Negative pressure wound therapy<br>* Wound dressing<br>* Other names: vacuum assisted closure;|
| Active Comparator: Control<br>Micropore tape | Other: Micropore tape<br>* Wound dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with seroma | One or more inguinal seroma(s) which require aspiration | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of seromas for each participant | Number of aspirated seromas (No.) | 3 months | 
| Volume of seromas for each participant | Volume of aspirated seromas (mL) | 3 months | 
| Number of participants with surgical wound infection | Inguinal wound infection which require antibiotic treatment | 3 months | 
| Number of participants with wound rupture | Inguinal wound rupture which require addition suturing or NPWT treatment | 3 months | 
| Number of participants with wound necrosis | Inguinal wound necrosis which require debridement | 3 months | 
| Number of participants with hematoma | Inguinal wound hematoma which require evacuation | 3 months | 
| Questionnaire EQ-5D-5L | Quality of life measurement score | Baseline, 3 months and 2 years | 
| Hospitalization time | Length of hospital stay until discharge (days) | 3 months | 
| Hospitalization readmission time | Length of hospital readmissions (days) | 3 months | 
| Number of participants with reoperations | Re-operation with opening of the wound or scar under general anesthesia due to adverse complications | 3 months | 
| Number of participants with lymphedema | Clinical evaluation using the International Lymphedema Society staging | 2 years | 
| Questionnaire LYMQOL | Lymphedema quality of life measurement score | 2 years | 
| Number of participants with regional recurrence | Histological verified recurrence to the inguinal site | 2 years |