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

NCT02237118 | Completed Results

• 1 other identifier: MPTO 05
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Acute; wound; management; measured; Visual analoge scale

Outcome Measures

Primary Outcomes (1)

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

  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.

  21 days

Secondary Outcomes (4)

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

  21 days

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

  21 days

• Safety

  21 days

• Assessment of the Surrounding Skin.

  21 days

Study Arms (2)

Mepitel One

ACTIVE COMPARATOR

Pain on dressing removal, by VAS

Device: Mepitel One; Device: UrgoTul

UrgoTul

ACTIVE COMPARATOR

Pain on removal by VAS

Device: Mepitel One; Device: UrgoTul

Interventions

Mepitel One DEVICE

Mepitel One; UrgoTul

UrgoTul DEVICE

Mepitel One; UrgoTul

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (1)

Clinique Mutualiste du Medoc

Lespare, 33340, France

Location

MeSH Terms

Conditions

Pain; Wounds and Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Anne Solanilla
• Organization: Clinique Mutualiste du Medoc

annasolanilla@yahoo.fr

+33 5 56 73 11 43

Study Officials

• Anna Solanilla, Dr

  Clinique Mutualiste du Medoc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 11, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2014-09

Locations

FR (1)