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

University of Oslo (UIO)

Status: Unknown

Conditions: Skin Cancer

Treatments: Device: PICO; Other: Coban 2 lite

Study type: Interventional

Funder types: Other

Identifiers

NCT03452852

2017/1603-5

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

NPWT (PICO device)

Other group

Description:

In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers.

Treatment:

Device: PICO

Compression bandaging (Coban 2 lite)

Other group

Description:

In this arm, investigators will use the Coban 2 lite compression bandaging for compression therapy after split thickness skin graft of leg ulcers.

Treatment:

Other: Coban 2 lite