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

Odense University Hospital20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Seroma Surgical Site Infection Lymphedema Quality of Life

Interventions

Negative pressure wound therapyDEVICE

Wound dressing

Micropore tapeOTHER

Wound dressing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Dept. of Plastic Surgery, Rigshospitalet

Copenhagen, Denmark

Dept. of Plastic Surgery, Herlev Gentofte Hospital

Herlev, Denmark

Dept. of Plastic Surgery, Odense University Hospital

Odense, Denmark

Dept. of Plastic Surgery, Roskilde Hospital

Roskilde, Denmark

Outcomes

Primary Outcomes

Number of participants with seroma

One or more inguinal seroma(s) which require aspiration

Time frame: 3 months

Secondary Outcomes

Number of seromas for each participant

Number of aspirated seromas (No.)

Time frame: 3 months

Volume of seromas for each participant

Volume of aspirated seromas (mL)

Time frame: 3 months

Number of participants with surgical wound infection

Inguinal wound infection which require antibiotic treatment

Time frame: 3 months

Number of participants with wound rupture

Inguinal wound rupture which require addition suturing or NPWT treatment

Time frame: 3 months

Number of participants with wound necrosis

Inguinal wound necrosis which require debridement

Time frame: 3 months

Number of participants with hematoma

Inguinal wound hematoma which require evacuation

Time frame: 3 months

Questionnaire EQ-5D-5L

Quality of life measurement score

Time frame: Baseline, 3 months and 2 years

Hospitalization time

Length of hospital stay until discharge (days)

Time frame: 3 months

Hospitalization readmission time

Length of hospital readmissions (days)

Time frame: 3 months

Number of participants with reoperations

Re-operation with opening of the wound or scar under general anesthesia due to adverse complications

Time frame: 3 months

Number of participants with lymphedema

Clinical evaluation using the International Lymphedema Society staging

Time frame: 2 years

Questionnaire LYMQOL

Lymphedema quality of life measurement score

Time frame: 2 years

Number of participants with regional recurrence

Histological verified recurrence to the inguinal site

Time frame: 2 years

Data from ClinicalTrials.gov

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