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N/A Completed N=159 Randomized Treatment

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

Acute Wounds
Source: ClinicalTrials.gov NCT03897465 ↗
Enrolled (actual)
159
Serious AEs
1.9%
Results posted
Feb 2025
Primary outcomePrimary: Percentage of Wound Dressing Changes Associated With a Pain <30 mm on Visual Analog Scale (VAS) — 97.4; 97.5 percentage of dressing changes

Summary

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

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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