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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | After subcuticular skin suture, patients receive standard dressing with adhesive wound tapes. |
|
| Incisional negative pressure group | Experimental | After subcuticular skin suture, patients receive an incisional negative pressure dressing for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incisional negative pressure wound therapy | Other | A negative pressure dressing is applied to the skin incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of drainage fluid | Measurement of total fluid amounts in drains and negative pressure device | up to 14 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Wound complications | Assessment of course of wound healing, necessary operative revisions, seroma formation | 3 months |
| Wound margin perfusion | Measurement with laser doppler |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Björn Behr, MD | Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum | Principal Investigator |
| Mehran Dadras, MD | Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil | Bochum | North Rhine-Westphalia | 44789 | Germany |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D008067 | Lipoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D018205 | Neoplasms, Adipose Tissue |
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| ID | Term |
|---|---|
| D001458 | Bandages |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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RCT with two therapy arms.
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| Wound dressing with adhesive tapes | Other | Regular adhesive wound tapes are applied over the closed skin. |
|
| 5 days postoperatively |