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

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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

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE March 2, 2018
Last Update Posted Date March 2, 2018
Estimated Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2018)
  • Percentage of healing between the two Methods [ Time Frame: 30 days postoperatively ]
    Average healing of the split thickness skin grafts
  • 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
  • Level of function [ Time Frame: 30 days postoperatively ]
    Evaluate change in daily function after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective, RCT of Split Thickness Skin Grafts on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
Official Title  ICMJE Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Skin Cancer
Intervention  ICMJE
  • Device: PICO
    NPWT with PICO (Smith and Nephew)
  • Other: Coban 2 lite
    Compression bandaging with Coban 2 lite
Study Arms  ICMJE
  • 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.
    Intervention: Device: PICO
  • 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.
    Intervention: Other: Coban 2 lite
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 26, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Martina Kristiansen, MD +47 6809453 martk4@ous-hf.no
Contact: Elisabeth Valio Sætnan, MD +47 980 96613 elsaet@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03452852
Other Study ID Numbers  ICMJE 2017/1603-5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martina Eva Kristiansen, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Moe Berg, MD, PhD Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway
PRS Account Oslo University Hospital
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP