MelanomaNCT04583605
The Aim of This Study is to Demonstrat That Vacuum-assisted Closure Versus Conventional Wound Closure Enables to Diminish Local Complications After Lymph Node Dissection in Patients With Metastatic Skin Tumors
An observational study of Melanoma and Skin Cancer, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Skin Cancer, Epidermoid Carcinoma
- What is being tested?
- PREVENA
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2014to 30 Sep 2020
- Phase
- Observational
- 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
Study population: major patient affected by a metastatic skin tumors
Who may be able to join
- major patient affected by a metastatic skin tumors
- the primitive skin tumor is either a mélanoma, either squamous cell carcinoma , or a neuroendocrine tumor
Who cannot join
- lymph node dissection resumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does PREVENA Vacuum-assisted Closure Reduce Lymphorrhoea Compared to Conventional Wound Closure After Axillary and Inguinal Lymph Node Dissection in the Management of Metastatic Cutaneous Skin Tumors ?
In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.
Read the detailed description
Lymphorrhoea, lymphedema and lymphocyte are significant and common complications after axillary and inguinal lymph nodes dissections. A vacuum assisted closure therapy should prevent these comorbidities. In this study, we compared PREVENA, a negative pressure wound therapy, versus conventional dressings. We evaluated the wound complications at the seventh day, the thirtieth day and at this end of the first year after surgery. It is a retrospective study of about ninety lymph nodes dissections among with there were seventy times the use of a negative pressure wound therapy, PREVENA.
- Conditions
- Melanoma, Skin Cancer, Epidermoid Carcinoma, Neuroendocrine Carcinoma, Lymph Node Metastases
- Being tested
- PREVENA
- Keywords
- vacuum assisted closure, PRENEVA, lymph node dissection
- Medical subject headings
- Melanoma, Skin Neoplasms, Carcinoma, Squamous Cell, Carcinoma, Neuroendocrine, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVENADevice
A negative pressure wound closure therapy is used after lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| PREVENA | A vacuum wound closure therapy like PREVENA is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors Receives: Device: PREVENA | |
| NON PREVENA | A conventional wound closure is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is there a visible scar disunion ?
Yes if there is a scar opening, no if there isn't
Measured: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Is there lymphorrhoea from the scar ?
Yes if there is lymph coming from the the scar, no if there isn't.
Measured: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Secondary outcomes (2)
Are there lymphocele punctures ?
Yes if there is any lymphocele puncture, no if there isn't
Measured: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Is there any lymphoedema ?
Yes if there is arm or leg lymphoedema, no if there isn't
Measured: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Jan 2014
- Primary completion13 Sep 2020
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuela PEREZ, Study director, Visceral Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583605
- Sponsor's protocol ID
- MR004
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Poirier A, Albuisson E, Bihain F, Granel-Brocard F, Perez M. Does Preventive Negative Pressure Wound Therapy (NPWT) reduce local complications following Lymph Node Dissection (LND) in the management of metastatic skin tumors? J Plast Reconstr Aesthet Surg. 2022 Dec;75(12):4403-4409. doi: 10.1016/j.bjps.2022.08.054. Epub 2022 Aug 24.
PubMed 36283927
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does PREVENA Vacuum-assisted Closure Reduce Lymphorrhoea Compared to Conventional Wound Closure After Axillary and Inguinal Lymph Node Dissection in the Management of Metastatic Cutaneous Skin Tumors ?
- ClinicalTrials.gov ID
- NCT04583605
- Acronym / sponsor ID
- MR004
- Conditions
- Melanoma, Skin Cancer, Epidermoid Carcinoma, Neuroendocrine Carcinoma, Lymph Node Metastases
- Keywords
- vacuum assisted closure, PRENEVA, lymph node dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 13 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 12 Oct 2020 (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.
In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.
Detailed description
Lymphorrhoea, lymphedema and lymphocyte are significant and common complications after axillary and inguinal lymph nodes dissections. A vacuum assisted closure therapy should prevent these comorbidities. In this study, we compared PREVENA, a negative pressure wound therapy, versus conventional dressings. We evaluated the wound complications at the seventh day, the thirtieth day and at this end of the first year after surgery. It is a retrospective study of about ninety lymph nodes dissections among with there were seventy times the use of a negative pressure wound therapy, PREVENA.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREVENA | – | Device: PREVENAA vacuum wound closure therapy like PREVENA is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors |
| NON PREVENA | – | –A conventional wound closure is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- major patient affected by a metastatic skin tumors
Key inclusion criteria (2 listed)
- major patient affected by a metastatic skin tumors
- the primitive skin tumor is either a mélanoma, either squamous cell carcinoma , or a neuroendocrine tumor
Key exclusion criteria (1 listed)
- lymph node dissection resumption
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 |
|---|---|---|
| PREVENAA negative pressure wound closure therapy is used after lymph node dissection | Device | PREVENA |
Primary outcome
Is there a visible scar disunion ?
Time frame: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Yes if there is a scar opening, no if there isn't
Is there lymphorrhoea from the scar ?
Time frame: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Yes if there is lymph coming from the the scar, no if there isn't.
2 secondary outcomes
Are there lymphocele punctures ?
Time frame: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Is there any lymphoedema ?
Time frame: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Derived from this study: PubMed 36283927Poirier A, Albuisson E, Bihain F, Granel-Brocard F, Perez M. Does Preventive Negative Pressure Wound Therapy (NPWT) reduce local complications following Lymph Node Dissection (LND) in the management of metastatic skin tumors? J Plast Reconstr Aesthet Surg. 2022 Dec;75(12):4403-4409. doi: 10.1016/j.bjps.2022.08.054. Epub 2022 Aug 24.
- Individual participant dataSharing planned: Undecided
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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.
Manuela PEREZ study director
Visceral Surgery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Skin Cancer, run by Central Hospital, Nancy, France at 1 site in France.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
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?
Is there a visible scar disunion ? (time frame: between day 1 and day 7, between day 7 and day 30, between day 30 and first year end). The study lists 2 primary outcomes in all. 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 NCT04583605, which also lists 1 linked publication.
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 12 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.