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

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ClinicalTrials.gov Identifier: NCT03433937
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Mads Gustaf Jørgensen, Odense University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Seroma Surgical Site Infection Lymphedema Quality of Life Device: Negative pressure wound therapy Other: Micropore tape Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Negative pressure wound therapy Device: Negative pressure wound therapy
Wound dressing
Other Name: vacuum assisted closure

Active Comparator: Control
Micropore tape
Other: Micropore tape
Wound dressing




Primary Outcome Measures :
  1. Number of participants with seroma [ Time Frame: 3 months ]
    One or more inguinal seroma(s) which require aspiration


Secondary Outcome Measures :
  1. Number of seromas for each participant [ Time Frame: 3 months ]
    Number of aspirated seromas (No.)

  2. Volume of seromas for each participant [ Time Frame: 3 months ]
    Volume of aspirated seromas (mL)

  3. Number of participants with surgical wound infection [ Time Frame: 3 months ]
    Inguinal wound infection which require antibiotic treatment

  4. Number of participants with wound rupture [ Time Frame: 3 months ]
    Inguinal wound rupture which require addition suturing or NPWT treatment

  5. Number of participants with wound necrosis [ Time Frame: 3 months ]
    Inguinal wound necrosis which require debridement

  6. Number of participants with hematoma [ Time Frame: 3 months ]
    Inguinal wound hematoma which require evacuation

  7. Questionnaire EQ-5D-5L [ Time Frame: Baseline, 3 months and 2 years ]
    Quality of life measurement score

  8. Hospitalization time [ Time Frame: 3 months ]
    Length of hospital stay until discharge (days)

  9. Hospitalization readmission time [ Time Frame: 3 months ]
    Length of hospital readmissions (days)

  10. Number of participants with reoperations [ Time Frame: 3 months ]
    Re-operation with opening of the wound or scar under general anesthesia due to adverse complications

  11. Number of participants with lymphedema [ Time Frame: 2 years ]
    Clinical evaluation using the International Lymphedema Society staging

  12. Questionnaire LYMQOL [ Time Frame: 2 years ]
    Lymphedema quality of life measurement score

  13. Number of participants with regional recurrence [ Time Frame: 2 years ]
    Histological verified recurrence to the inguinal site



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433937


Contacts
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Contact: Mads G Jørgensen 22163425 ext +45 Mads.Gustaf.Jorgensen@rsyd.dk

Locations
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Denmark
Dept. of Plastic Surgery, Herlev Gentofte Hospital Recruiting
Herlev, Denmark
Contact: Lisbet R Hölmich, DrMedSci         
Dept. of Plastic Surgery, Rigshospitalet Recruiting
København, Denmark
Contact: Jennifer B Drejøe, MD         
Dept. of Plastic Surgery, Odense University Hospital Recruiting
Odense, Denmark
Contact: Mads G Jørgensen, MD         
Dept. of Plastic Surgery, Roskilde Hospital Recruiting
Roskilde, Denmark
Contact: Steen Matzen, DrMedSci         
Sponsors and Collaborators
Odense University Hospital
Investigators
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Study Chair: Jens A Sørensen Department of Plastic Surgery, Odense University Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mads Gustaf Jørgensen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03433937     History of Changes
Other Study ID Numbers: S-20170085
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Lymphedema
Surgical Wound Infection
Seroma
Lymphatic Diseases
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Inflammation