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

O

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)

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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