Efficacy, safety and ease of use of a thin Algostéril in the local care of wounds
| ISRCTN | ISRCTN14026011 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14026011 |
| Secondary identifying numbers | n°ID RCB 2015-400810-49 |
- Submission date
- 04/01/2016
- Registration date
- 06/01/2016
- Last edited
- 22/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Les laboratoires Brothier
41 rue de Neuilly
Nanterre
92735
France
Study information
| Study design | Monocentric prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Efficacy, safety and ease of use of a thin Algostéril in the local care of wounds: a monocentric prospective study |
| Study objectives | The aim of this study is to demonstrate that a thin Algostéril is effective at wound healing. |
| Ethics approval(s) | Persons Protection Committee (Comité de Protection des Personnes) CPP Nord-Ouest II, 25/09/2015, ref: 2015 / 44 |
| Health condition(s) or problem(s) studied | Wounds |
| Intervention | Each patient is treated with a Algostéril dressing until wound healing in about one month. |
| Intervention type | Other |
| 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 study start date | 12/06/2015 |
| Completion date | 31/01/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key exclusion criteria | Participant or participating in another clinical trial within 30 days prior to inclusion |
| Date of first enrolment | 04/12/2015 |
| Date of final enrolment | 04/12/2016 |
Locations
Countries of recruitment
- France
Study participating centre
France
Sponsor information
Industry
41 rue de neuilly
Nanterre
92735
France
"ROR" |
https://ror.org/007jkh405 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | All study results will be published in the same publication. |
| IPD sharing plan | The data sharing plans for this study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 22/02/2022 | No | No |
Additional files
Editorial Notes
22/02/2022: The basic results have been uploaded as an additional file.
26/07/2018: IPD sharing statement added.
11/07/2018: The following changes were made to the trial record:
1. The overall trial end date was changed from 04/12/2015 to 31/01/2020.
2. The intention to publish date was changed from 31/12/2017 to 01/03/2020.
