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

Primary Purpose

Acute Wounds

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lomatuell Pro
UrgoTul
Sponsored by
Lohmann & Rauscher
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CICA+

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lomatuell Pro

UrgoTul

Arm Description

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.

UrgoTul® is a flexible contact layer with TLC healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles.

Outcomes

Primary Outcome Measures

Percentage of wound dressing changes associated with a pain <30 mm on Visual Analog Scale (VAS)
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.

Secondary Outcome Measures

Complete healing: Percentage of epithelialization of the wound at V3 calculated based on a blind assessment from photographs using W.H.A.T. assessment
Condition of the wound
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
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
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
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
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)
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

Full Information

First Posted
March 21, 2019
Last Updated
November 30, 2022
Sponsor
Lohmann & Rauscher
Collaborators
RCTs
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1. Study Identification

Unique Protocol Identification Number
NCT03897465
Brief Title
Comparative Evaluation of the propertieS of the Contact LAyer Dressing LOMatuell Pro® Versus UrgoTul® in the Management of Acute Wounds
Acronym
SLALOM
Official Title
Comparative Evaluation of the propertieS of the Contact LAyer Dressing LOMatuell Pro® Versus UrgoTul® in the Management of Acute Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
December 6, 2020 (Actual)
Study Completion Date
December 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lohmann & Rauscher
Collaborators
RCTs

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Wounds

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lomatuell Pro
Arm Type
Experimental
Arm Description
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.
Arm Title
UrgoTul
Arm Type
Active Comparator
Arm Description
UrgoTul® is a flexible contact layer with TLC healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles.
Intervention Type
Device
Intervention Name(s)
Lomatuell Pro
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
UrgoTul
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of wound dressing changes associated with a pain <30 mm on Visual Analog Scale (VAS)
Description
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.
Time Frame
At Visit 2 (Day 3 ± 2 days)
Secondary Outcome Measure Information:
Title
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)
Title
Condition of the wound
Description
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.
Time Frame
At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)
Title
Condition of the surrounding skin
Description
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.
Time Frame
At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)
Title
Global assessment of exudate management
Description
This will use a Cochran-Mantel-Haenszel test including treatment groups and baseline wound exudation status (none, light and moderate/heavy).
Time Frame
At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)
Title
Investigator's global assessment of the product
Description
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.
Time Frame
At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)
Title
Patient's global assessment of the product
Description
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.
Time Frame
At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)
Title
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)
Description
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
Time Frame
At Visit 2 (Day 3 ± 2 days) and Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daria TROFIMENKO
Organizational Affiliation
Lohmann & Rauscher
Official's Role
Study Director
Facility Information:
Facility Name
CICA+
City
Limonest
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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