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

Pain Clinical Trial

— Only  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237118
• Other study ID #: MPTO 05
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: February 23, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2014
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Mepitel One

• UrgoTul

Locations

Country	Name	City	State
France	Clinique Mutualiste du Medoc	Lespare

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measured by VAS	To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal, pain measured by VAS	21 days	No
Secondary	Complete healing at day 21, will be measured using PictZar system.	Complete healing at day 21, will be measured using PictZar system.	21 days	No
Secondary	Condition of the wound, will be assesst by the investigator.	wound size estimation, assesstemnt of the wound, assessment of the woundbed, assessment of the surrounding skin.	21 days	Yes
Secondary	Safety	Adverse Event, Serious Adverse Event, Adverse Device Event	21 days	Yes