NCT03433937

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

January 30, 2018

Last Update Submit

June 24, 2021

Conditions

SeromaSurgical Site InfectionLymphedemaQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Number of participants with seroma

    One or more inguinal seroma(s) which require aspiration

    3 months

Secondary Outcomes (13)

  • Number of seromas for each participant

    3 months

  • Volume of seromas for each participant

    3 months

  • Number of participants with surgical wound infection

    3 months

  • Number of participants with wound rupture

    3 months

  • Number of participants with wound necrosis

    3 months

  • +8 more secondary outcomes

Study Arms (2)

Negative pressure wound therapy

EXPERIMENTAL
Device: Negative pressure wound therapy

Control

ACTIVE COMPARATOR

Micropore tape

Other: Micropore tape

Interventions

Negative pressure wound therapyDEVICE

Wound dressing

Also known as: vacuum assisted closure
Negative pressure wound therapy
Micropore tapeOTHER

Wound dressing

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dept. of Plastic Surgery, Rigshospitalet

Copenhagen, Denmark

Location

Dept. of Plastic Surgery, Herlev Gentofte Hospital

Herlev, Denmark

Location

Dept. of Plastic Surgery, Odense University Hospital

Odense, Denmark

Location

Dept. of Plastic Surgery, Roskilde Hospital

Roskilde, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 29246739BACKGROUND

  • 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.

    PMID: 36304071DERIVED

  • 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.

    PMID: 30111378DERIVED

MeSH Terms

Conditions

SeromaSurgical Wound InfectionLymphedema

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsWound InfectionInfectionsPostoperative ComplicationsLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Jens A Sørensen

    Department of Plastic Surgery, Odense University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 15, 2018

Study Start

April 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(4)