An interventional study of Negative pressure wound therapy and Micropore tape in Seroma, Surgical Site Infection and Lymphedema, sponsored by Odense University Hospital. Terminated at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-29.
Sponsored by Odense University Hospital · Not applicable, Interventional, and Prevention
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.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Negative pressure wound therapy
Micropore tape
Other: Micropore tape
Wound dressing
Also known as: vacuum assisted closure
Wound dressing
Number of participants with seroma
One or more inguinal seroma(s) which require aspiration
Time frame: 3 months
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
Plan to share: No
Ran from Apr 2018 to primary completion in Sep 2020, 29 months.
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This study is terminated, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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