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

• Conditions: Lymph Node Metastases; Epidermoid Carcinoma; Neuroendocrine Carcinoma; Melanoma; Skin Cancer
• Interventions: Device: PREVENA

• Registration Number: NCT04583605
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2014-01-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-20
• Primary Completion: 2020-09-13
• Study Completion: 2020-09-30
• Study First Submitted QC: 2020-10-06
• Last Update Submitted: 2020-10-06
• Study First Posted: 2020-10-12
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHRU; 🇫🇷 Nancy, France