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

Molnlycke Health Care

Status: Completed

Conditions: Pain

Treatments: Device: Mepitel One; Device: UrgoTul

Study type: Interventional

Funder types: Industry

Identifiers

NCT02237118

MPTO 05

Details and patient eligibility

About

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

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Surgical wound
2. Infected, moderately to strongly exudative and haemorrhagic wound
3. Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, ...) which, as judged by the investigator, could interfere with the pain assessment
4. Known allergy/hypersensitivity to any of the components of the investigational products
5. Participation in other clinical investigation within one month prior to start of investigation
6. Pregnant or breast-feeding women
7. Person protected by a legal regime (tutorship or guardianship)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Mepitel One

Active Comparator group

Description:

Pain on dressing removal, by VAS

Treatment:

Device: UrgoTul

Device: Mepitel One

UrgoTul

Active Comparator group

Description:

Pain on removal by VAS

Treatment:

Device: UrgoTul

Device: Mepitel One