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 ?

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04583605

Enrollment

Registered

2020-10-12

Start date

2014-01-01

Completion date

2020-09-30

Last updated

2020-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

vacuum assisted closure, PRENEVA, lymph node dissection

Brief 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. 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.

Interventions

DEVICEPREVENA

A negative pressure wound closure therapy is used after lymph node dissection

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Is there a visible scar disunion ?	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 ?	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.

Secondary

Measure	Time frame	Description
Are there lymphocele punctures ?	between day 1 and day 7, between day 7 and day 30, between day 30 and first year end	Yes if there is any lymphocele puncture, no if there isn't
Is there any lymphoedema ?	between day 1 and day 7, between day 7 and day 30, between day 30 and first year end	Yes if there is arm or leg lymphoedema, no if there isn't

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026