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

October 6, 2020 updated by: Central Hospital, Nancy, France

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

major patient affected by a metastatic skin tumors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PREVENA
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 ?
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.
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 ?
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 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 ?
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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Director: Manuela PEREZ, Visceral Surgery Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

September 13, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

July 20, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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