Prospective, RCT of Split Thickness Skin Grafts on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT

Conditions
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Skin Cancer

Intervention / Treatment
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* Device: PICO
* Other: Coban 2 lite


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NPWT (PICO device)<br>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<br>* NPWT with PICO (Smith and Nephew)<br>|
| Other: Compression bandaging (Coban 2 lite)<br>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<br>* Compression bandaging with Coban 2 lite<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 0, 5-7, 10-14 and 30 days postoperatively | 
| Level of function | Evaluate change in daily function after surgery | 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Split thickness skin graft, Lower leg, Compression therapy, PICO, Coban 2 lite