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

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03452852
• Other study ID #: 2017/1603-5
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2018
• Last updated: February 26, 2018
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2018
• Source: Oslo University Hospital
• Contact: Martina Kristiansen, MD
• Phone: +47 6809453
• Email: martk4[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Device:
• PICO
NPWT with PICO (Smith and Nephew)

Other:
• Coban 2 lite
Compression bandaging with Coban 2 lite

Locations

Country	Name	City	State
Norway	Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing of skin graft between the two Methods	Numbers of patients with 100 % healing of the split thickness skin graft	30 days postoperatively
Secondary	Percentage of healing between the two Methods	Average healing of the split thickness skin grafts	30 days postoperatively
Secondary	Evaluation of pain with VAS (Visual analogic scale)	Pain score as measured by VAS	0, 5-7, 10-14 and 30 days postoperatively
Secondary	Level of function	Evaluate change in daily function after surgery	30 days postoperatively