N/A
N=159
Lomatuell Pro® Versus UrgoTul® in the Management of Acute Wounds
Acute Wounds
Bottom Line
View on ClinicalTrials.gov: NCT03897465 ↗Enrolled (actual)
159
Serious AEs
1.9%
Results posted
Feb 2025
Primary outcome: Primary: Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS) — 97.4; 97.5 percentage of dressing changes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lomatuell Pro (Device); UrgoTul (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lohmann & Rauscher
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS) |
97.4; 97.5 | — |
| SECONDARY Complete Healing |
48; 55 | — |
Summary
Comparative evaluation of the propertieS of the contact LAyer dressing LOMatuell Pro® versus UrgoTul® in the management of acute wounds
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 (visual analogue scale) tool
- Patient not covered by health insurance/social security
Data sourced from ClinicalTrials.gov (NCT03897465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.