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

Melanoma Clinical Trial

Official title:

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 ?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04583605
• Other study ID #: MR004
• Status: Active, not recruiting
• Start date: January 1, 2014
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 30, 2020
• Est. primary completion date: September 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Neuroendocrine
• Carcinoma, Squamous Cell
• Epidermoid Carcinoma
• Lymph Node Metastases
• Melanoma
• Neuroendocrine Carcinoma
• Skin Cancer
• Skin Neoplasms

Intervention

Device:
• PREVENA
A negative pressure wound closure therapy is used after lymph node dissection

Locations

Country	Name	City	State
France	CHRU	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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