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

NCT ID: NCT04583605

Last Updated: 2020-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2020-09-30

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.

Conditions

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Melanoma Skin Cancer Epidermoid Carcinoma Neuroendocrine Carcinoma Lymph Node Metastases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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PREVENA

A vacuum wound closure therapy like PREVENA is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors

PREVENA

Intervention Type DEVICE

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

NON PREVENA

A conventional wound closure is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors

No interventions assigned to this group

Interventions

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PREVENA

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manuela PEREZ

Role: STUDY_DIRECTOR

Visceral Surgery Department

Locations

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CHRU

Nancy, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 36283927 (View on PubMed)

Other Identifiers

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MR004

Identifier Type: -

Identifier Source: org_study_id

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