Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452852
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Martina Eva Kristiansen, 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.


Condition or disease Intervention/treatment Phase
Skin Cancer Device: PICO Other: Coban 2 lite Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: PICO
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.
Other: Coban 2 lite
Compression bandaging with Coban 2 lite




Primary Outcome Measures :
  1. Healing of skin graft between the two Methods [ Time Frame: 30 days postoperatively ]
    Numbers of patients with 100 % healing of the split thickness skin graft


Secondary Outcome Measures :
  1. Percentage of healing between the two Methods [ Time Frame: 30 days postoperatively ]
    Average healing of the split thickness skin grafts

  2. Evaluation of pain with VAS (Visual analogic scale) [ Time Frame: 0, 5-7, 10-14 and 30 days postoperatively ]
    Pain score as measured by VAS

  3. Level of function [ Time Frame: 30 days postoperatively ]
    Evaluate change in daily function after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452852


Contacts
Layout table for location contacts
Contact: Martina Kristiansen, MD +47 6809453 martk4@ous-hf.no
Contact: Elisabeth Valio Sætnan, MD +47 980 96613 elsaet@ous-hf.no

Locations
Layout table for location information
Norway
Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet Recruiting
Oslo, Norway, 0372
Contact: Martina Kristiansen, MD    +47 46809453    martk4@ous-hf.no   
Contact: Thomas Moe Berg, MD, PhD    +47 41328958    thmobe@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Thomas Moe Berg, MD, PhD Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway

Layout table for additonal information
Responsible Party: Martina Eva Kristiansen, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03452852     History of Changes
Other Study ID Numbers: 2017/1603-5
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Martina Eva Kristiansen, Oslo University Hospital:
Split thickness skin graft
Lower leg
Compression therapy
PICO
Coban 2 lite
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Monensin
Antifungal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Proton Ionophores
Uncoupling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ionophores
Membrane Transport Modulators
Sodium Ionophores