Inzisionelle Negative Drucktherapie Nach Resektion Von Weichteiltumoren - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Amount of drainage fluid
Study Overview
Brief Summary
This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.
Detailed Description
Wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. Aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Soft tissue tumor of extremities or trunk with expected resection of >10cm tissue in any dimension.
Exclusion Criteria
- •No primary skin closure.
- •Skin infection in area of operation (e.g. acne inversa).
Outcomes
Primary Outcomes
Amount of drainage fluid
Time Frame: up to 14 days postoperatively
Measurement of total fluid amounts in drains and negative pressure device
Secondary Outcomes
- Wound complications(3 months)
- Wound margin perfusion(5 days postoperatively)
Investigators
Mehran Dadras, MD
Consultant, Department of Plastic Surgery
Ruhr University of Bochum