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

Not Applicable

• Conditions: Skin Cancer
• Interventions: Device: PICO; Other: Coban 2 lite

• Registration Number: NCT03452852
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-02-26
• Last Update Submitted: 2018-02-26
• Study Start: 2018-03-01
• Study First Posted: 2018-03-02
• Last Update Posted: 2018-03-02
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPWT (PICO device)	PICO	In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers.
Compression bandaging (Coban 2 lite)	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.

Primary Outcome Measures

Name	Time	Method
Healing of skin graft between the two Methods	30 days postoperatively	Numbers of patients with 100 % healing of the split thickness skin graft

Secondary Outcome Measures

Name	Time	Method
Evaluation of pain with VAS (Visual analogic scale)	0, 5-7, 10-14 and 30 days postoperatively	Pain score as measured by VAS
Percentage of healing between the two Methods	30 days postoperatively	Average healing of the split thickness skin grafts
Level of function	30 days postoperatively	Evaluate change in daily function after surgery

Trial Locations

Locations (1)

Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet; 🇳🇴 Oslo, Norway