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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-11

Study Completion Date

2020-12-06

Brief Summary

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

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Detailed Description

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

Conditions

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Acute Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lomatuell Pro

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

UrgoTul

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No