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 ?
1 other identifier
observational
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 12, 2020
CompletedOctober 12, 2020
July 1, 2020
6.7 years
July 20, 2020
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Are there lymphocele punctures ?
between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Is there any lymphoedema ?
between day 1 and day 7, between day 7 and day 30, between day 30 and first year end
Study Arms (2)
PREVENA
A vacuum wound closure therapy like PREVENA is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors
NON PREVENA
A conventional wound closure is applied after axillary or inguinal lymph node dissection in the management of metastatic skin tumors
Interventions
Eligibility Criteria
major patient affected by a metastatic skin tumors
You may qualify if:
- major patient affected by a metastatic skin tumors
- the primitive skin tumor is either a mélanoma, either squamous cell carcinoma , or a neuroendocrine tumor
You may not qualify if:
- lymph node dissection resumption
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU
Nancy, 54000, France
Related Publications (1)
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.
PMID: 36283927DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Manuela PEREZ
Visceral Surgery Department
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2020
First Posted
October 12, 2020
Study Start
January 1, 2014
Primary Completion
September 13, 2020
Study Completion
September 30, 2020
Last Updated
October 12, 2020
Record last verified: 2020-07