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TerminatedNCT03433937Updated Jun 29, 2021

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

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

Why this study was terminated
Low inclusion
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Seroma
  • Surgical Site Infection
  • Lymphedema
  • Quality of Life
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All malignant melanoma patients who are candidates for ILND and 18 years of age or older

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Negative pressure wound therapy

    Device: Negative pressure wound therapy

  • Active comparator
    Control

    Micropore tape

    Other: Micropore tape

Interventions

  • DeviceNegative pressure wound therapy

    Wound dressing

    Also known as: vacuum assisted closure

  • OtherMicropore tape

    Wound dressing

05

What researchers measure

Primary outcomes

  1. Number of participants with seroma

    One or more inguinal seroma(s) which require aspiration

    Time frame: 3 months

Secondary outcomes

  1. Number of seromas for each participant

    Number of aspirated seromas (No.)

    Time frame: 3 months

  2. Volume of seromas for each participant

    Volume of aspirated seromas (mL)

    Time frame: 3 months

  3. Number of participants with surgical wound infection

    Inguinal wound infection which require antibiotic treatment

    Time frame: 3 months

  4. Number of participants with wound rupture

    Inguinal wound rupture which require addition suturing or NPWT treatment

    Time frame: 3 months

  5. Number of participants with wound necrosis

    Inguinal wound necrosis which require debridement

    Time frame: 3 months

  6. Number of participants with hematoma

    Inguinal wound hematoma which require evacuation

    Time frame: 3 months

  7. Questionnaire EQ-5D-5L

    Quality of life measurement score

    Time frame: Baseline, 3 months and 2 years

  8. Hospitalization time

    Length of hospital stay until discharge (days)

    Time frame: 3 months

  9. Hospitalization readmission time

    Length of hospital readmissions (days)

    Time frame: 3 months

  10. 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

  11. Number of participants with lymphedema

    Clinical evaluation using the International Lymphedema Society staging

    Time frame: 2 years

  12. Questionnaire LYMQOL

    Lymphedema quality of life measurement score

    Time frame: 2 years

  13. Number of participants with regional recurrence

    Histological verified recurrence to the inguinal site

    Time frame: 2 years

06

Study locations

4 sites
  • Dept. of Plastic Surgery, Herlev Gentofte Hospital
    Herlev, Denmark
  • Dept. of Plastic Surgery, Rigshospitalet
    København, Denmark
  • Dept. of Plastic Surgery, Odense University Hospital
    Odense, Denmark
  • Dept. of Plastic Surgery, Roskilde Hospital
    Roskilde, Denmark
07

References and documents

Publications

  • Jorgensen MG, Toyserkani NM, Thomsen JB, Sorensen JA. Surgical-site infection following lymph node excision indicates susceptibility for lymphedema: A retrospective cohort study of malignant melanoma patients. J Plast Reconstr Aesthet Surg. 2018 Apr;71(4):590-596. doi: 10.1016/j.bjps.2017.11.026. Epub 2017 Nov 28. PubMed 29246739 ↗
  • Jorgensen MG, Chakera AH, Holmich LR, Drejoe JB, Andersen PCL, Khorasani H, Toyserkani NM, Thomsen JB, Sorensen JA. Can prophylactic incisional negative pressure wound therapy Reduce Wound Complications After Inguinal Lymph Node Dissection for Melanoma? Results from a Randomized Controlled Trial. JPRAS Open. 2022 Aug 26;34:134-143. doi: 10.1016/j.jpra.2022.08.003. eCollection 2022 Dec. PubMed 36304071 ↗
  • Jorgensen MG, Toyserkani NM, Hyldig N, Chakera AH, Holmich LR, Thomsen JB, Sorensen JA. Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial. Trials. 2018 Aug 15;19(1):441. doi: 10.1186/s13063-018-2757-6. Erratum In: Trials. 2018 Oct 19;19(1):570. doi: 10.1186/s13063-018-2882-2. PubMed 30111378 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03433937
Lead sponsor
Odense University Hospital
Responsible party
Mads Gustaf Jørgensen (MD, Odense University Hospital) — Principal investigator
First posted
Feb 15, 2018
Start date
Apr 1, 2018
Primary completion
Sep 1, 2020
Completion
Sep 1, 2020
Last update
Jun 29, 2021

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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