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

February 24, 2017 updated by: Molnlycke Health Care AB
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lespare, France, 33340
        • Clinique Mutualiste du Medoc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mepitel One
Pain on dressing removal, by VAS
Device: Mepitel One
Device: UrgoTul
Active Comparator: UrgoTul
Pain on removal by VAS
Device: Mepitel One
Device: UrgoTul

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)
Time Frame: 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.
21 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molnlycke Health Care AB

Investigators

  • Principal Investigator: Anna Solanilla, Dr, Clinique Mutualiste du Medoc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 5, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

February 24, 2017

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MPTO 05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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