Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Evaluation of the propertieS of the Contact LAyer Dressing LOMatuell Pro® Versus UrgoTul® in the Management of Acute Wounds (SLALOM)

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: NCT03897465
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
RCTs
Information provided by (Responsible Party):
Lohmann & Rauscher

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE April 1, 2019
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE February 11, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
Percentage of wound dressing changes associated with a pain <30 mm on Visual Analog Scale (VAS) [ Time Frame: At Visit 2 (Day 3 ± 2 days) ]
A specific ruler will be provided to the investigator in order to measure the VAS score. The subject will mark on the ruler the point that he/she feels represent his/her perception of his/her current pain. The VAS score will be directly measured by the investigator with a scale in millimetres. The VAS score will be filled in the CRF.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • Complete healing: Percentage of epithelialization of the wound at V3 calculated based on a blind assessment from photographs using W.H.A.T. assessment [ Time Frame: At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) ]
  • Condition of the wound [ Time Frame: At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) ]
    The wound bed condition will be evaluated regarding 6 condition items: bleeding, maceration, inflammation, infection, ratio necrotic/ fibrinous/ granulation/ epithelisation tissue, and tissue in-growth in the dressing holes, by means of the following 4-points scale: none, mild, moderate, severe. The percentage of each modality for each condition items will be calculated.
  • Condition of the surrounding skin [ Time Frame: At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) ]
    The condition of the surrounding skin will be assessed regarding different conditions: inflammatory signs, irritation, allergic rash/eczema, blistering, skin stripping, maceration, dry, trauma to wound edges, product degradation on the skin, hematoma, other. These condition items will be assessed by means of the scale Yes/No. The percentage of each modality will be calculated.
  • Global assessment of exudate management [ Time Frame: At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) ]
    This will use a Cochran-Mantel-Haenszel test including treatment groups and baseline wound exudation status (none, light and moderate/heavy).
  • Investigator's global assessment of the product [ Time Frame: At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) ]
    The global assessment of the dressing will be performed by the investigator regarding the following items: ease of handling, ability to maintain its integrity, ease of application, ability to be repositioned during application, conformability, wound adhesion, ability of dressings to stay in place, transparency, ability to transfer wound fluid to the secondary dressing, ease / speed of removal, overall impression, and absence of residue. Each item will be evaluated by means of the following scale: very good, good, poor, and very poor. The percentage of each modality will be presented.
  • Patient's global assessment of the product [ Time Frame: At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) ]
    The global assessment of the dressing will be performed by the subject regarding the following items: ability to maintain its integrity, ability of dressings to stay in place, transparency, comfort of the patient, ability to transfer wound fluid to the secondary dressing, ease/speed of removal, overall impression. Each item will be evaluated by means of the following scale: very good, good, moderate, poor, very poor. The percentage of each modality will be presented.
  • Safety endpoint: frequency and character of device deficiencies (DDs), adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs) [ Time Frame: At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized) ]
    Safety analyses will be descriptive overall and by dressing group. Any local and general adverse events occurring and those already present, but worsening, during the course of the investigation will be described on the safety population. Frequencies will be provided per dressing group and overall describing the type of event: device deficiency (DD), adverse event (AE), serious AE (SAE), adverse device effect (ADE), serious ADE
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 Comparative Evaluation of the propertieS of the Contact LAyer Dressing LOMatuell Pro® Versus UrgoTul® in the Management of Acute Wounds
Official Title  ICMJE Comparative Evaluation of the propertieS of the Contact LAyer Dressing LOMatuell Pro® Versus UrgoTul® in the Management of Acute Wounds
Brief Summary Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds
Detailed Description National, multicenter, prospective, randomized in parallel groups, non-inferiority, open-label investigation study.
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 Acute Wounds
Intervention  ICMJE
  • Device: Lomatuell Pro
    Patients will receive Lomatuell Pro dressings during 3 weeks. Lomatuell Pro® may be left in place up to 7 days; additional dressing changes can be performed as often as necessary according to the instruction for use.
  • Device: UrgoTul
    Patients will receive UrgoTul dressings during 3 weeks. UrgoTul® may be left in place up to 7 days; ; additional dressing changes can be performed as often as necessary according to the instruction for use.
Study Arms  ICMJE
  • Experimental: Lomatuell Pro
    Lomatuell Pro® is a wound contact layer consisting of wide-meshed tulle, impregnated with a polymer matrix, which form a gel on contact with wound exudate to facilitate moist wound healing.
    Intervention: Device: Lomatuell Pro
  • Active Comparator: UrgoTul
    UrgoTul® is a flexible contact layer with TLC healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles.
    Intervention: Device: UrgoTul
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: March 29, 2019)
168
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute wound: traumatic wound (dermabrasion, skin tears, other), small burns 1st and 2nd degree requiring the use of dressings
  • Acute wound size between 3 cm² and 24 cm² (wound could be covered by 2 investigational products maximum)
  • Wound whose duration is ≤ 3 days
  • Both gender with an age ≥ 18 years
  • Written confirmation from the study nurse that the patient was informed, orally agreed to participate and to comply with study treatment and planned visits
  • Subject able to follow the protocol

Exclusion Criteria:

  • Chronic and acute surgical wound
  • Infected, moderately to strongly exudative and haemorrhagic wound
  • Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, etc.) which as judged by the investigator could interfere with the pain assessment
  • Known allergy/hypersensitivity to any of the components of the investigational products
  • Participation in other clinical investigation within one month prior to start of investigation
  • Pregnant or breast-feeding women
  • Person protected by a legal regime (tutorship or guardianship)
  • Patients unable to manifest an oral consent to participate (e.g. dementia) or to understand the use of the VAS tool
  • Patient not covered by health insurance/social security
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aurore MAGNY +33437451714 ama@rcts.fr
Contact: Hélène VELASQUEZ-GIRON +33437451721 hvg@rcts.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03897465
Other Study ID Numbers  ICMJE 2018-A02288-47
Has Data Monitoring Committee No
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 Lohmann & Rauscher
Study Sponsor  ICMJE Lohmann & Rauscher
Collaborators  ICMJE RCTs
Investigators  ICMJE
Study Director: Daria TROFIMENKO Lohmann & Rauscher
PRS Account Lohmann & Rauscher
Verification Date March 2019

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