Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors
- Conditions
- Soft Tissue SarcomaLipomaTumor
- Registration Number
- NCT03900078
- Lead Sponsor
- Ruhr University of Bochum
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Soft tissue tumor of extremities or trunk with expected resection of >10cm tissue in any dimension.
- No primary skin closure.
- Skin infection in area of operation (e.g. acne inversa).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Amount of drainage fluid up to 14 days postoperatively Measurement of total fluid amounts in drains and negative pressure device
- Secondary Outcome Measures
Name Time Method Wound complications 3 months Assessment of course of wound healing, necessary operative revisions, seroma formation
Wound margin perfusion 5 days postoperatively Measurement with laser doppler
Trial Locations
- Locations (1)
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
🇩🇪Bochum, NRW, Germany
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil🇩🇪Bochum, NRW, Germany