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

Primary Purpose

Seroma, Surgical Site Infection, Lymphedema

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Negative pressure wound therapy
Micropore tape
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seroma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Plastic Surgery, Herlev Gentofte Hospital
  • Dept. of Plastic Surgery, Rigshospitalet
  • Dept. of Plastic Surgery, Odense University Hospital
  • Dept. of Plastic Surgery, Roskilde Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative pressure wound therapy

Control

Arm Description

Micropore tape

Outcomes

Primary Outcome Measures

Number of participants with seroma
One or more inguinal seroma(s) which require aspiration

Secondary Outcome Measures

Number of seromas for each participant
Number of aspirated seromas (No.)
Volume of seromas for each participant
Volume of aspirated seromas (mL)
Number of participants with surgical wound infection
Inguinal wound infection which require antibiotic treatment
Number of participants with wound rupture
Inguinal wound rupture which require addition suturing or NPWT treatment
Number of participants with wound necrosis
Inguinal wound necrosis which require debridement
Number of participants with hematoma
Inguinal wound hematoma which require evacuation
Questionnaire EQ-5D-5L
Quality of life measurement score
Hospitalization time
Length of hospital stay until discharge (days)
Hospitalization readmission time
Length of hospital readmissions (days)
Number of participants with reoperations
Re-operation with opening of the wound or scar under general anesthesia due to adverse complications
Number of participants with lymphedema
Clinical evaluation using the International Lymphedema Society staging
Questionnaire LYMQOL
Lymphedema quality of life measurement score
Number of participants with regional recurrence
Histological verified recurrence to the inguinal site

Full Information

First Posted
January 30, 2018
Last Updated
June 24, 2021
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03433937
Brief Title
Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
Official Title
Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Low inclusion
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma, Surgical Site Infection, Lymphedema, Quality of Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative pressure wound therapy
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Micropore tape
Intervention Type
Device
Intervention Name(s)
Negative pressure wound therapy
Other Intervention Name(s)
vacuum assisted closure
Intervention Description
Wound dressing
Intervention Type
Other
Intervention Name(s)
Micropore tape
Intervention Description
Wound dressing
Primary Outcome Measure Information:
Title
Number of participants with seroma
Description
One or more inguinal seroma(s) which require aspiration
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of seromas for each participant
Description
Number of aspirated seromas (No.)
Time Frame
3 months
Title
Volume of seromas for each participant
Description
Volume of aspirated seromas (mL)
Time Frame
3 months
Title
Number of participants with surgical wound infection
Description
Inguinal wound infection which require antibiotic treatment
Time Frame
3 months
Title
Number of participants with wound rupture
Description
Inguinal wound rupture which require addition suturing or NPWT treatment
Time Frame
3 months
Title
Number of participants with wound necrosis
Description
Inguinal wound necrosis which require debridement
Time Frame
3 months
Title
Number of participants with hematoma
Description
Inguinal wound hematoma which require evacuation
Time Frame
3 months
Title
Questionnaire EQ-5D-5L
Description
Quality of life measurement score
Time Frame
Baseline, 3 months and 2 years
Title
Hospitalization time
Description
Length of hospital stay until discharge (days)
Time Frame
3 months
Title
Hospitalization readmission time
Description
Length of hospital readmissions (days)
Time Frame
3 months
Title
Number of participants with reoperations
Description
Re-operation with opening of the wound or scar under general anesthesia due to adverse complications
Time Frame
3 months
Title
Number of participants with lymphedema
Description
Clinical evaluation using the International Lymphedema Society staging
Time Frame
2 years
Title
Questionnaire LYMQOL
Description
Lymphedema quality of life measurement score
Time Frame
2 years
Title
Number of participants with regional recurrence
Description
Histological verified recurrence to the inguinal site
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens A Sørensen
Organizational Affiliation
Department of Plastic Surgery, Odense University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Plastic Surgery, Herlev Gentofte Hospital
City
Herlev
Country
Denmark
Facility Name
Dept. of Plastic Surgery, Rigshospitalet
City
København
Country
Denmark
Facility Name
Dept. of Plastic Surgery, Odense University Hospital
City
Odense
Country
Denmark
Facility Name
Dept. of Plastic Surgery, Roskilde Hospital
City
Roskilde
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29246739
Citation
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.
Results Reference
background
PubMed Identifier
36304071
Citation
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.
Results Reference
derived
PubMed Identifier
30111378
Citation
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.
Results Reference
derived

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

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