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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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 ?

Conditions
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Melanoma, Skin Cancer, Epidermoid Carcinoma, Neuroendocrine Carcinoma, Lymph Node Metastases

Intervention / Treatment
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* Device: PREVENA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PREVENA<br>A vacuum wound closure therapy like PREVENA is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors | Device: PREVENA<br>* A negative pressure wound closure therapy is used after lymph node dissection<br>|
| NON PREVENA<br>A conventional wound closure is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there a visible scar disunion ? | Yes if there is a scar opening, no if there isn't | 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. | between day 1 and day 7, between day 7 and day 30, between day 30 and first year end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Are there lymphocele punctures ? | Yes if there is any lymphocele puncture, no if there isn't | 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 | between day 1 and day 7, between day 7 and day 30, between day 30 and first year end | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vacuum assisted closure, PRENEVA, lymph node dissection