Clinical trial · Observational
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
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 ?
NCT04583605CI-TRIAL-00047622unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epidermoid Carcinoma | Squamous Cell Carcinoma | ALIAS | 0.90 |
| Lymph Node Metastases | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PREVENA | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PREVENA
- description
- A vacuum wound closure therapy like PREVENA is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors
- interventionNames
- Device: PREVENA
- label
- NON PREVENA
- description
- A conventional wound closure is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors
Primary outcomes (2)
- measure
- Is there a visible scar disunion ?
- timeFrame
- between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
- description
- Yes if there is a scar opening, no if there isn't
- measure
- Is there lymphorrhoea from the scar ?
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * major patient affected by a metastatic skin tumors * the primitive skin tumor is either a mélanoma, either squamous cell carcinoma , or a neuroendocrine tumor Exclusion Criteria: * lymph node dissection resumption
References
Publications (1)
- DERIVEDPoirier 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. PMID 36283927