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

NCT03433937 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-06-29

No results posted yet for this study

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.

Conditions

  • Seroma
  • Surgical Site Infection
  • Lymphedema
  • Quality of Life

Interventions

DEVICE

Negative pressure wound therapy

Wound dressing

OTHER

Micropore tape

Wound dressing

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Jens A Sørensen · Department of Plastic Surgery, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2020-09-01
Completion
2020-09-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433937 on ClinicalTrials.gov