Skin Cancer
Conditions
Keywords
Split thickness skin graft, Lower leg, Compression therapy, PICO, Coban 2 lite
Brief summary
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.
Interventions
DEVICEPICO
NPWT with PICO (Smith and Nephew)
OTHERCoban 2 lite
Compression bandaging with Coban 2 lite
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \>18 years * Signed informed consent * Surgical wound (excision of skin cancer)
Exclusion criteria
* Malignant melanoma * Signs of infection * Exposed tendon/bone in wound * Burn/chronic wound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of skin graft between the two Methods | 30 days postoperatively | Numbers of patients with 100 % healing of the split thickness skin graft |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of healing between the two Methods | 30 days postoperatively | Average healing of the split thickness skin grafts |
| Evaluation of pain with VAS (Visual analogic scale) | 0, 5-7, 10-14 and 30 days postoperatively | Pain score as measured by VAS |
| Level of function | 30 days postoperatively | Evaluate change in daily function after surgery |
Countries
Norway
Contacts
Primary ContactMartina Kristiansen, MD
Backup ContactElisabeth Valio Sætnan, MD
Outcome results
None listed