Lomatuell Pro® Versus UrgoTul® in the Management of Acute Wounds (SLALOM)

September 30, 2025 updated by: Lohmann & Rauscher

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

Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

National, multicenter, prospective, randomized in parallel groups, non-inferiority, open-label investigation study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
183

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limonest, France
        • CICA+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 (visual analogue scale) tool
  • Patient not covered by health insurance/social security

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Active Comparator: UrgoTul
UrgoTul® is a flexible contact layer with TLC (Technology Lipido-Colloid) healing matrix comprised of a conformable polyester mesh impregnated with hydrocolloid and petroleum jelly particles.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
To evaluate the main study objective, patients were asked to assess the pain they felt during the first dressing removal (D3±2 days) with a means of visual analog scale (VAS), a 100 mm straight line ranging from 0 to 100, where "0" refers to "no pain" and "100" to the "worst pain imaginable". The VAS score was directly measured by the investigator with a scale in millimetres and the number was entered in the patient's case report from (CRF).
At Visit 2 (Day 3 ± 2 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Healing
Time Frame: At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)
Percentage of epithelialization of the wound at V3 calculated based on a blind assessment of wound photographs using W.H.A.T. assessment (W.H.A.T. = Wound Healing Analysing Tool is a program for assessment of the wound photos, which allows to obtain automatically-calculated results for wound area, wound dimensions, % of necrotic, granulation or epithelium tissues in the wound bed). "Complete healing" was defined as 100% of the wound area covered by the epithelium.
At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lohmann & Rauscher

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RCTs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Daria TROFIMENKO, Lohmann & Rauscher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-A02288-47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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