Plain English Summary
Background and study aims
Algostéril is a calcium alginate wound dressing, made from seaweed. It works by providing a moistened environment for the wound which helps the healing process. This study looks at how effective the dressing is at healing wounds.
Who can participate?
Adults with a wound that needs dressing.
What does the study involve?
Each patient is treated with a Algostéril dressing until their wound is healed.
What are the possible benefits and risks of participating?
The potential benefits to participating in this study include quick wound healing, using a dressing that is easy to use and remove. No risks have been identified.
Where is the study run from?
CHU Amiens-Picardie (University Hospital Centre) (France)
When is the study starting and how long is it expected to run for?
June 2015 to December 2015
Who is funding the study?
Laboratoires Brothier (France)
Who is the main contact?
Dr Mueser Maryse
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
n°ID RCB 2015-400810-49
Study information
Scientific title
Efficacy, safety and ease of use of a thin Algostéril in the local care of wounds: a monocentric prospective study
Acronym
Study hypothesis
The aim of this study is to demonstrate that a thin Algostéril is effective at wound healing.
Ethics approval
Persons Protection Committee (Comité de Protection des Personnes) CPP Nord-Ouest II, 25/09/2015, ref: 2015 / 44
Study design
Monocentric prospective study
Primary study design
Interventional
Secondary study design
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Wounds
Intervention
Each patient is treated with a Algostéril dressing until wound healing in about one month.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Number of days of treatment to obtain the wound healing, checked by the methylene blue test
Secondary outcome measures
1. Ease of use
2. Assessment of safety throughout the trial
Overall trial start date
12/06/2015
Overall trial end date
31/01/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patient :
1. aged 18 years or older
2. with a wound that needs to be treated by a thin Algostéril
3. who can be followed until the wound healing
4. who signed informed consent form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Participant or participating in another clinical trial within 30 days prior to inclusion
Recruitment start date
04/12/2015
Recruitment end date
04/12/2016
Locations
Countries of recruitment
France
Trial participating centre
CHU Amiens-Picardie (University Hospital Centre)
80054
France
Funders
Funder type
Industry
Funder name
Brothier pharmaceutical laboratory
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
All study results will be published in the same publication.
IPD sharing statement
The data sharing plans for this study are unknown and will be made available at a later date.
Intention to publish date
01/03/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list