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

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: Completed
• Conditions: Acute Wounds
• Intervention / Treatment: Device: Lomatuell Pro; Device: UrgoTul

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limonest, France
    • CICA+

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Visit 3 (Day 21 or earlier, as soon as the wound is epithelialized)

Collaborators and Investigators

• Sponsor: Lohmann & Rauscher
• Collaborators: RCTs
• Investigators: Study Director: Daria TROFIMENKO, Lohmann & Rauscher

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): December 6, 2020
• Study Completion (Actual): December 6, 2020

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID 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