Soft Tissue Sarcoma, Lipoma, Tumor
Conditions
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.
Interventions
A negative pressure dressing is applied to the skin incision.
OTHERWound dressing with adhesive tapes
Regular adhesive wound tapes are applied over the closed skin.
Sponsors
Ruhr University of Bochum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
RCT with two therapy arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of drainage fluid | up to 14 days postoperatively | Measurement of total fluid amounts in drains and negative pressure device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed