An interventional study of PICO and Coban 2 lite in Skin Cancer, sponsored by Oslo University Hospital. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-02.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers.
Device: PICO
In this arm, investigators will use the Coban 2 lite compression bandaging for compression therapy after split thickness skin graft of leg ulcers.
Other: Coban 2 lite
NPWT with PICO (Smith and Nephew)
Compression bandaging with Coban 2 lite
Healing of skin graft between the two Methods
Numbers of patients with 100 % healing of the split thickness skin graft
Time frame: 30 days postoperatively
Percentage of healing between the two Methods
Average healing of the split thickness skin grafts
Time frame: 30 days postoperatively
Evaluation of pain with VAS (Visual analogic scale)
Pain score as measured by VAS
Time frame: 0, 5-7, 10-14 and 30 days postoperatively
Level of function
Evaluate change in daily function after surgery
Time frame: 30 days postoperatively
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital