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

Odense University Hospital

Status: Terminated

Conditions: Quality of Life; Surgical Site Infection; Seroma; Lymphedema

Treatments: Device: Negative pressure wound therapy; Other: Micropore tape

Study type: Interventional

Funder types: Other

Identifiers

NCT03433937

S-20170085

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Negative pressure wound therapy

Experimental group

Treatment:

Device: Negative pressure wound therapy

Control

Active Comparator group

Description:

Micropore tape

Treatment:

Other: Micropore tape