Acute WoundsSLALOMNCT03897465

Lomatuell Pro® Versus UrgoTul® in the Management of Acute Wounds

A study testing Lomatuell Pro and UrgoTul in people with Acute Wounds, run by Lohmann & Rauscher at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Wounds
What is being tested?: Lomatuell Pro and UrgoTul
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 183 participants
Where: 1 siteFrance
Study dates: 11 Feb 2019to 6 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

France1 site

CICA+
Limonest

Other trials in France

About this study

Official title: 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

Read the detailed description

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

Conditions: Acute Wounds
Being tested: Lomatuell Pro, UrgoTul

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lomatuell ProDevice
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.
UrgoTulDevice
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 groups in NCT03897465
Study group	Role	What they receive
Lomatuell Pro	Experimental	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. Receives: Device: Lomatuell Pro
UrgoTul	Active comparator	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. Receives: Device: UrgoTul

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS)
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).
Measured: At Visit 2 (Day 3 ± 2 days)

Secondary outcomes (1)

Complete Healing
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.
Measured: At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 20196 Dec 2020

First posted1 Apr 2019
Study start11 Feb 2019
Primary completion6 Dec 2020
Study completion6 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute WoundsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03897465
Sponsor's protocol ID: 2018-A02288-47
Acronym: SLALOM
Status last verified: Sep 2025
First submitted: 21 Mar 2019
Last updated: 29 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Meaume S, Kerihuel JC, Malatesta A, Roux F, Trofimenko D, Abel M. Non-inferiority randomised controlled trial of two contact layer dressings for the treatment of acute wounds (SLALOM). J Wound Care. 2025 Jul 2;34(7):496-505. doi: 10.12968/jowc.2024.0312.
PubMed 40632070

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Evaluation of the propertieS of the Contact LAyer Dressing LOMatuell Pro® Versus UrgoTul® in the Management of Acute Wounds
ClinicalTrials.gov ID: NCT03897465
Acronym / sponsor ID: SLALOM / 2018-A02288-47
Conditions: Acute Wounds
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: Lohmann & RauscherIndustry (pharma, biotech, devices)
Collaborators: RCTs
Study start: 11 Feb 2019 (actual)
Primary completion: 6 Dec 2020 (actual)
Study completion: 6 Dec 2020 (actual)
First posted: 1 Apr 2019 (actual)
Results: Posted 7 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lomatuell Pro	Experimental	Device: Lomatuell ProLomatuell 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	Active comparator	Device: UrgoTulUrgoTul® 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lomatuell ProPatients 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	Lomatuell Pro
UrgoTulPatients 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.	Device	UrgoTul

Primary outcome

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).

1 secondary outcome

Complete Healing
Time frame: At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)

Results and safety

Results posted to the registry on 7 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lomatuell Pro	78	71
UrgoTul	81	79

Primary outcome: 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). Number (95% Confidence Interval). Unit: percentage of dressing changes

Measure	Lomatuell Pro n = 77	UrgoTul n = 81
Value	97.4 (97.01 to 98.06)	97.5 (97.12 to 98.16)

Lomatuell Pro vs UrgoTul: Risk Difference (RD): 1.4

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For each patient, adverse events were collected for maximum of 23 days from Baseline (D0) till the Final study visit (Day 21+2). There was no follow-up period in the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lomatuell Pro	3 of 78 (3.8%)	0 of 78 (0%)	0 of 78
UrgoTul	0 of 81 (0%)	1 of 81 (1.2%)	0 of 81

Limitations and caveats (from the sponsor): Open-label investigation design (nurses and patients knew which dressing was applied); Subjective pain scores assessment (by the patients).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40632070Meaume S, Kerihuel JC, Malatesta A, Roux F, Trofimenko D, Abel M. Non-inferiority randomised controlled trial of two contact layer dressings for the treatment of acute wounds (SLALOM). J Wound Care. 2025 Jul 2;34(7):496-505. doi: 10.12968/jowc.2024.0312.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daria TROFIMENKO study director

Lohmann & Rauscher

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lomatuell Pro and UrgoTul in people with Acute Wounds, run by Lohmann & Rauscher at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03897465, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.