N/A
N=123
Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02237118 ↗Enrolled (actual)
123
Serious AEs
4.1%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS) — 44; 39 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mepitel One (Device); UrgoTul (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS) |
44; 39 | — |
| SECONDARY Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System. |
0.89; 0.52 | — |
| SECONDARY Condition of the Wound, Will be Assesst by the Investigator. |
41; 38; 16; 18; 2; 2 | — |
| SECONDARY Safety |
6; 7; 1; 0; 53; 56 | — |
| SECONDARY Assessment of the Surrounding Skin. |
4; 7; 2; 3; 0; 1 | — |
Summary
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02237118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.