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

NCT03897465 | Completed Results

• 1 other identifier: 2018-A02288-47
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Wounds

Outcome Measures

Primary Outcomes (1)

• 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).

  At Visit 2 (Day 3 ± 2 days)

Secondary Outcomes (1)

• Complete Healing

  At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)

Study Arms (2)

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.

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.

Device: UrgoTul

Interventions

Lomatuell Pro DEVICE

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.

Lomatuell Pro

UrgoTul DEVICE

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.

UrgoTul

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lohmann & Rauscher: lead
• RCTs: collaborator

Study Sites (1)

CICA+

Limonest, France

Location

Related Publications (1)

• 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.

  PMID: 40632070 RESULT

Limitations and Caveats

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

Results Point of Contact

• Title: Dr Daria Trofimenko, Senior Manager Clinical Regulatory Affairs
• Organization: Lohmann & Rauscher GmbH & Co. KG

Daria.Trofimenko@de.LRMed.com

+49 (0) 2631 99 6385

Study Officials

• Daria TROFIMENKO

  Lohmann & Rauscher

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 1, 2019
• Study Start: February 11, 2019
• Primary Completion: December 6, 2020
• Study Completion: December 6, 2020
• Last Updated: October 29, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-09

Locations

FR (1)