Prospective, RCT of Split Thickness Skin Grafts on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
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|ClinicalTrials.gov Identifier: NCT03452852|
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer||Device: PICO Other: Coban 2 lite||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT|
|Estimated Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
NPWT (PICO device)
In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers.
NPWT with PICO (Smith and Nephew)
Compression bandaging (Coban 2 lite)
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
Compression bandaging with Coban 2 lite
- Healing of skin graft between the two Methods [ Time Frame: 30 days postoperatively ]Numbers of patients with 100 % healing of the split thickness skin graft
- Percentage of healing between the two Methods [ Time Frame: 30 days postoperatively ]Average healing of the split thickness skin grafts
- Evaluation of pain with VAS (Visual analogic scale) [ Time Frame: 0, 5-7, 10-14 and 30 days postoperatively ]Pain score as measured by VAS
- Level of function [ Time Frame: 30 days postoperatively ]Evaluate change in daily function after surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452852
|Contact: Martina Kristiansen, MD||+47 firstname.lastname@example.org|
|Contact: Elisabeth Valio Sætnan, MD||+47 980 email@example.com|
|Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet||Recruiting|
|Oslo, Norway, 0372|
|Contact: Martina Kristiansen, MD +47 46809453 firstname.lastname@example.org|
|Contact: Thomas Moe Berg, MD, PhD +47 41328958 email@example.com|
|Principal Investigator:||Thomas Moe Berg, MD, PhD||Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway|