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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: Mepitel One; Device: UrgoTul

• Registration Number: NCT02237118
• Lead Sponsor: Molnlycke Health Care AB

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-11
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Results First Submitted: 2016-05-03
• Results First Submitted QC: 2017-02-24
• Last Update Submitted: 2017-02-24
• Results First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepitel One	UrgoTul	Pain on dressing removal, by VAS
UrgoTul	UrgoTul	Pain on removal by VAS
Mepitel One	Mepitel One	Pain on dressing removal, by VAS
UrgoTul	Mepitel One	Pain on removal by VAS

Primary Outcome Measures

Name	Time	Method
Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)	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 Outcome Measures

Name	Time	Method
Condition of the Wound, Will be Assesst by the Investigator.	21 days	wound size estimation, assesstemnt of the wound,
Safety	21 days	Adverse Event, Adverse Device Event
Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.	21 days	Complete healing at day 21, will be measured using PictZar system.
Assessment of the Surrounding Skin.	21 days	assessment of the surrounding skin.

Trial Locations

Locations (1)

Clinique Mutualiste du Medoc; 🇫🇷 Lespare, France