SeromaNCT03433937
Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
A study testing Negative pressure wound therapy and Micropore tape in people with Seroma and Surgical Site Infection, run by Odense University Hospital at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seroma, Surgical Site Infection, Lymphedema
- What is being tested?
- Negative pressure wound therapy and Micropore tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Apr 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All malignant melanoma patients who are candidates for ILND and 18 years of age or older
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Dept. of Plastic Surgery, Rigshospitalet
Copenhagen
Dept. of Plastic Surgery, Herlev Gentofte Hospital
Herlev
Dept. of Plastic Surgery, Odense University Hospital
Odense
Dept. of Plastic Surgery, Roskilde Hospital
Roskilde
About this study
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.
- Conditions
- Seroma, Surgical Site Infection, Lymphedema, Quality of Life
- Being tested
- Negative pressure wound therapy, Micropore tape
- Medical subject headings
- Seroma, Surgical Wound Infection, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound therapyDevice
Also called vacuum assisted closure
Wound dressing
Micropore tapeOther
Wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure wound therapy | Experimental | Not described Receives: Device: Negative pressure wound therapy |
| Control | Active comparator | Micropore tape Receives: Other: Micropore tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with seroma
One or more inguinal seroma(s) which require aspiration
Measured: 3 months
Secondary outcomes (13)
Number of seromas for each participant
Number of aspirated seromas (No.)
Measured: 3 months
Volume of seromas for each participant
Volume of aspirated seromas (mL)
Measured: 3 months
Number of participants with surgical wound infection
Inguinal wound infection which require antibiotic treatment
Measured: 3 months
Number of participants with wound rupture
Inguinal wound rupture which require addition suturing or NPWT treatment
Measured: 3 months
Number of participants with wound necrosis
Inguinal wound necrosis which require debridement
Measured: 3 months
Number of participants with hematoma
Inguinal wound hematoma which require evacuation
Measured: 3 months
Questionnaire EQ-5D-5L
Quality of life measurement score
Measured: Baseline, 3 months and 2 years
Hospitalization time
Length of hospital stay until discharge (days)
Measured: 3 months
Hospitalization readmission time
Length of hospital readmissions (days)
Measured: 3 months
Number of participants with reoperations
Re-operation with opening of the wound or scar under general anesthesia due to adverse complications
Measured: 3 months
Number of participants with lymphedema
Clinical evaluation using the International Lymphedema Society staging
Measured: 2 years
Questionnaire LYMQOL
Lymphedema quality of life measurement score
Measured: 2 years
Number of participants with regional recurrence
Histological verified recurrence to the inguinal site
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 Apr 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Why it stopped: Low inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SeromaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mads Gustaf Jørgensen, Odense University Hospital
- Investigators
- Jens A Sørensen, Study chair, Department of Plastic Surgery, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433937
- Sponsor's protocol ID
- S-20170085
- Status last verified
- Jun 2021
- First submitted
- 30 Jan 2018
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29246739Jorgensen 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 36304071Jorgensen 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.
PubMed 30111378
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Seroma Following Inguinal Lymph Node Dissection With Prophylactic Incisional Negative Pressure Wound Therapy
- ClinicalTrials.gov ID
- NCT03433937
- Acronym / sponsor ID
- S-20170085
- Conditions
- Seroma, Surgical Site Infection, Lymphedema, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low inclusion
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative pressure wound therapy | Experimental | Device: Negative pressure wound therapy |
| Control | Active comparator | Other: Micropore tapeMicropore tape |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All malignant melanoma patients who are candidates for ILND and 18 years of age or older
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative pressure wound therapyAlso: vacuum assisted closureWound dressing | Device | Negative pressure wound therapy |
| Micropore tapeWound dressing | Other | Control |
Primary outcome
Number of participants with seroma
Time frame: 3 months
One or more inguinal seroma(s) which require aspiration
13 secondary outcomes
Number of seromas for each participant
Time frame: 3 months
Volume of seromas for each participant
Time frame: 3 months
Number of participants with surgical wound infection
Time frame: 3 months
Number of participants with wound rupture
Time frame: 3 months
Number of participants with wound necrosis
Time frame: 3 months
Number of participants with hematoma
Time frame: 3 months
Questionnaire EQ-5D-5L
Time frame: Baseline, 3 months and 2 years
Hospitalization time
Time frame: 3 months
Hospitalization readmission time
Time frame: 3 months
Number of participants with reoperations
Time frame: 3 months
Number of participants with lymphedema
Time frame: 2 years
Questionnaire LYMQOL
Time frame: 2 years
Number of participants with regional recurrence
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Low inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Background: PubMed 29246739Jorgensen 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.
- Derived from this study: PubMed 36304071Jorgensen 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.
- Derived from this study: PubMed 30111378Jorgensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens A Sørensen study chair
Department of Plastic Surgery, Odense University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure wound therapy and Micropore tape in people with Seroma and Surgical Site Infection, run by Odense University Hospital at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with seroma (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433937, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.