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The single center, prospective, randomized trial includes in total 60 patients. We want to compare two different treatment methods for compression therapy for split thickness skin graft in lower leg. The patients are randomized to compression therapy with NPWT (negative pressure wound therapy) using the device PICO or using the compression bandage with Coban 2 lite.
Primary outcome is complete healing of the skin transplant 30 days postoperatively. Secondary outcomes will be to note frequency of infection, bleeding, loss of transplant etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPWT (PICO device) | Other | In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers. |
|
| Compression bandaging (Coban 2 lite) | Other | In this arm, investigators will use the Coban 2 lite compression bandaging for compression therapy after split thickness skin graft of leg ulcers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICO | Device | NPWT with PICO (Smith and Nephew) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Healing of skin graft between the two Methods | Numbers of patients with 100 % healing of the split thickness skin graft | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of healing between the two Methods | Average healing of the split thickness skin grafts | 30 days postoperatively |
| Evaluation of pain with VAS (Visual analogic scale) | Pain score as measured by VAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martina Kristiansen, MD | Contact | +47 6809453 | martk4@ous-hf.no | |
| Elisabeth Valio Sætnan, MD | Contact | +47 980 96613 | elsaet@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Moe Berg, MD, PhD | Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet | Recruiting | Oslo | 0372 | Norway |
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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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| Coban 2 lite |
| Other |
Compression bandaging with Coban 2 lite |
|
| 0, 5-7, 10-14 and 30 days postoperatively |
| Level of function | Evaluate change in daily function after surgery | 30 days postoperatively |