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

Primary Purpose

Skin Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
PICO
Coban 2 lite
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Cancer focused on measuring Split thickness skin graft, Lower leg, Compression therapy, PICO, Coban 2 lite

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Department of Plastic- and Reconstructive Surgery, Oslo university hospital - RikshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

NPWT (PICO device)

Compression bandaging (Coban 2 lite)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Healing of skin graft between the two Methods
Numbers of patients with 100 % healing of the split thickness skin graft

Secondary Outcome Measures

Percentage of healing between the two Methods
Average healing of the split thickness skin grafts
Evaluation of pain with VAS (Visual analogic scale)
Pain score as measured by VAS
Level of function
Evaluate change in daily function after surgery

Full Information

First Posted
February 26, 2018
Last Updated
February 26, 2018
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03452852
Brief Title
Prospective, RCT of Split Thickness Skin Grafts on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
Official Title
Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
Keywords
Split thickness skin graft, Lower leg, Compression therapy, PICO, Coban 2 lite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NPWT (PICO device)
Arm Type
Other
Arm Description
In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers.
Arm Title
Compression bandaging (Coban 2 lite)
Arm Type
Other
Arm Description
In this arm, investigators will use the Coban 2 lite compression bandaging for compression therapy after split thickness skin graft of leg ulcers.
Intervention Type
Device
Intervention Name(s)
PICO
Intervention Description
NPWT with PICO (Smith and Nephew)
Intervention Type
Other
Intervention Name(s)
Coban 2 lite
Intervention Description
Compression bandaging with Coban 2 lite
Primary Outcome Measure Information:
Title
Healing of skin graft between the two Methods
Description
Numbers of patients with 100 % healing of the split thickness skin graft
Time Frame
30 days postoperatively
Secondary Outcome Measure Information:
Title
Percentage of healing between the two Methods
Description
Average healing of the split thickness skin grafts
Time Frame
30 days postoperatively
Title
Evaluation of pain with VAS (Visual analogic scale)
Description
Pain score as measured by VAS
Time Frame
0, 5-7, 10-14 and 30 days postoperatively
Title
Level of function
Description
Evaluate change in daily function after surgery
Time Frame
30 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Kristiansen, MD
Phone
+47 6809453
Email
martk4@ous-hf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Valio Sætnan, MD
Phone
+47 980 96613
Email
elsaet@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Moe Berg, MD, PhD
Organizational Affiliation
Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Kristiansen, MD
Phone
+47 46809453
Email
martk4@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Thomas Moe Berg, MD, PhD
Phone
+47 41328958
Email
thmobe@ous-hf.no

12. IPD Sharing Statement

Learn more about this trial

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

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