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This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.
Annually, 12 000 skin cancers are diagnosed in Finland. This randomized controlled non-sponsored trial evaluate if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications. 60 patients over 18 years of age are included and randomly assigned to either the negative pressure-treatment group or the conventional treatment group. At the control appointment one-week postsurgery, graft take is documented as a primary outcome and any complications (necrosis, infection, hematoma/seroma) and adverse events (pain, skin reactions) as secondary outcomes. Adverse events are evaluated by a phone call 3 weeks postsurgery and based on medical records 3 months postsurgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative-pressure treatment | Experimental | A negative pressure wound dressing is placed over the skin graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given. |
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| Conventional treatment | Active Comparator | A conventional antimicrobial wound dressing is placed on top of the graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative pressure device | Device | Negative-pressure therapy postoperatively on the full-thickness skin graft |
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| Measure | Description | Time Frame |
|---|---|---|
| Graft take | good, partial or poor graft take (%) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Necrosis, infection, hematoma/seroma (%) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUS Iho- ja allergiasairaala | Helsinki | 00250 | Finland |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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controlled study
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| Conventional care | Procedure | Conventional dressing postoperatively on the full-thickness skin graft |
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