NCT03452852

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

February 26, 2018

Last Update Submit

February 26, 2018

Conditions

Skin Cancer

Keywords

Split thickness skin graftLower legCompression therapyPICOCoban 2 lite

Outcome Measures

Primary Outcomes (1)

  • Healing of skin graft between the two Methods

    Numbers of patients with 100 % healing of the split thickness skin graft

    30 days postoperatively

Secondary Outcomes (3)

  • Percentage of healing between the two Methods

    30 days postoperatively

  • Evaluation of pain with VAS (Visual analogic scale)

    0, 5-7, 10-14 and 30 days postoperatively

  • Level of function

    30 days postoperatively

Study Arms (2)

NPWT (PICO device)

OTHER

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

Device: PICO

Compression bandaging (Coban 2 lite)

OTHER

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

Other: Coban 2 lite

Interventions

PICODEVICE

NPWT with PICO (Smith and Nephew)

NPWT (PICO device)
Coban 2 liteOTHER

Compression bandaging with Coban 2 lite

Compression bandaging (Coban 2 lite)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • Signed informed consent
  • Surgical wound (excision of skin cancer)

You may not qualify if:

  • Malignant melanoma
  • Signs of infection
  • Exposed tendon/bone in wound
  • Burn/chronic wound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Oslo, 0372, Norway

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thomas Moe Berg, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martina Kristiansen, MD

CONTACT

+47 6809453martk4@ous-hf.no

Elisabeth Valio Sætnan, MD

CONTACT

+47 980 96613elsaet@ous-hf.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 2, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

NO(1)