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OpenTrials
Completed

NCT Number: NCT02237118

Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"

To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Mutualiste du Medoc

Lespare, 33340, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring the use of dressings
  • Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum)
  • Wound whose duration is ≤ 3 days
  • Both gender with an age ≥ 18 years
  • Subject able to understand and voluntarily sign the informed consent
  • Subject able to follow the protocol
  • Subject insured to the French social security system

Exclusion criteria

  • Surgical wound
  • Infected, moderately to strongly exudative and haemorrhagic wound
  • Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, …) 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)

Treatment and study plan

Mepitel One

Device

URGOTUL

Device

Primary outcomes

  1. Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)

    Time frame: 21 days

    To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.

Secondary outcomes

  1. Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.

    Time frame: 21 days

    Complete healing at day 21, will be measured using PictZar system.

  2. Condition of the Wound, Will be Assesst by the Investigator.

    Time frame: 21 days

    wound size estimation, assesstemnt of the wound,

  3. Safety

    Time frame: 21 days

    Adverse Event, Adverse Device Event

  4. Assessment of the Surrounding Skin.

    Time frame: 21 days

    assessment of the surrounding skin.

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Acronym: Only

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 11, 2014
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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