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 ?

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: Melanoma; Skin Cancer; Neuroendocrine Carcinoma; Lymph Node Metastases; Epidermoid Carcinoma
• Intervention / Treatment: Device: PREVENA

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

Study Locations

• France
  • Nancy, France, 54000
    • CHRU

Participation Criteria

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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

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 ?	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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Director: Manuela PEREZ, Visceral Surgery Department

Study record dates

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: lymph node dissection; vacuum assisted closure; PRENEVA
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Neuroendocrine Tumors; Neoplasm Metastasis; Neoplasms, Squamous Cell; Carcinoma; Lymphatic Metastasis; Carcinoma, Squamous Cell; Carcinoma, Neuroendocrine
• 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