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

NCT ID: NCT03452852

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-12-31

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.

Conditions

Skin Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

PICO

Intervention Type: DEVICE

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.

Group Type: OTHER

Coban 2 lite

Intervention Type: OTHER

Compression bandaging with Coban 2 lite

Interventions

PICO

NPWT with PICO (Smith and Nephew)

Intervention Type: DEVICE

Coban 2 lite

Compression bandaging with Coban 2 lite

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Martina Eva Kristiansen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Moe Berg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway

Locations

Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Martina Kristiansen, MD

Role: CONTACT

martk4@ous-hf.no

+47 6809453

Elisabeth Valio Sætnan, MD

Role: CONTACT

elsaet@ous-hf.no

+47 980 96613

Facility Contacts

Martina Kristiansen, MD

Role: primary

martk4@ous-hf.no

+47 46809453

Thomas Moe Berg, MD, PhD

Role: backup

thmobe@ous-hf.no

+47 41328958

Other Identifiers

2017/1603-5

Identifier Type: -

Identifier Source: org_study_id