Treatment of pressure ulcers with Algosteril dressing
| ISRCTN | ISRCTN17449724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17449724 |
| EudraCT/CTIS number | 2021-A01344-37 |
| Secondary identifying numbers | N° ID-RCB 2021-A01344-37 |
- Submission date
- 07/09/2021
- Registration date
- 20/10/2021
- Last edited
- 14/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Pressure ulcers (also known as pressure sores or bedsores) are injuries to the skin and underlying tissue, primarily caused by prolonged pressure on the skin. They can happen to anyone, but usually affect people confined to bed or who sit in a chair or wheelchair for long periods of time.
In France, pressure ulcers affect approximately 300,000 people of all ages. The prevalence of pressure ulcers in the home, in patients over 65 years of age, was estimated in 2004 to be between 70,000 and 112,000 patients. It is a costly disease that has a significant impact on the quality of life of the person affected.
The prevention and healing of pressure ulcers is a key concern for caregivers. Algosteril dressing can be used for pressure ulcers treatment. Algostéril is a calcium alginate wound dressing, made from seaweed. The study aims is to evaluate wound healing efficacity of dressing Algosteril for treatment of pressure ulcers.
Who can participate?
Patients over 18 years of age with a stage 3 or 4 pressure ulcer can participate in this study.
What does the study involve?
Each patient is treated with Algosteril for 8 weeks at maximum. The dressing is replaced when required (every two days maximum). Pressure ulcer is examined every 2 weeks.
What are the possible benefits and risks of participating?
Algosteril is a dressing that promotes wound healing and also helps to stop bleeding from wounds. No particular risks or constraints were identified for patients participating in this study.
Where is the study run from?
HAD Santé Service (Levallois-Perret) (France)
When is the study starting and how long is it expected to run for?
August 2021 to November 2023
Who is funding the study?
Les Laboratoires Brothier (France)
Who is the main contact?
Melanie Angot, melanie.angot@brothier.com
Contact information
Scientific
41 rue de Neuilly
Nanterre
92735
France
| Phone | +33 (0)699074753 |
|---|---|
| angot@brothier.com |
Study information
| Study design | Multicenter observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participation information sheet |
| Scientific title | Non-interventional study on the evolution of pressure ulcers treated with Algosteril in Hospital at Home |
| Study acronym | AlgoDOM |
| Study objectives | A review of the literature over the last 5 years shows that no prospective clinical study evaluating the efficacy of a dressing for pressure ulcers in Hospital at Home has been conducted, although a large number of pressure ulcers are managed by Hospital at Home. |
| Ethics approval(s) | Approved 12/08/2021, Sud-Est IV Ethics Committee (Centre Léon Bérard, 28 rue Laennec, 69373 Lyon Cedex 08, France; +33 (0)4.78.78.27.61; ppse4@lyon.unicancer.fr), ref: none provided |
| Health condition(s) or problem(s) studied | Stage 3 or 4 pressure ulcer |
| Intervention | Each patient is treated with Algosteril and followed for a maximum of 8 weeks. 5 protocol visits are planned: Day of inclusion, Week 2, Week 4, Week 6 and Week 8 or Day of cicatrisation. Photo is taken at D inclusion, W2, W4, W6 and W8 or D cicatrisation, and surface of pressure ulcer is calculated at these visits. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Algostéril |
| Primary outcome measure | Efficacity is evaluated by the average relative reduction of the pressure ulcer surface. Surface is measured in cm² at D inclusion, W2, W4, W6 and W8 or D cicatrisation |
| Secondary outcome measures | 1. Efficacy evaluated by the average relative reduction of the pressure ulcer volume. Volume is measured in cm3 at D inclusion, W2, W4, W6 and W8 or D cicatrisation 2. Wound evolution measured using the amount of exudate estimated using a 4-point scale at each visit 3. Quality of peri-wound estimated at each visit using a 2-point scale 4. Presence or not of clinical signs of infection is described at each visit 5. Tolerance measured using adverse events related to Algosteril |
| Overall study start date | 12/08/2021 |
| Completion date | 14/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 97 |
| Key inclusion criteria | 1. Patients with stage 3 or 4 pressure ulcer 2. Aged 18 years or older |
| Key exclusion criteria | Head pressure ulcer |
| Date of first enrolment | 20/09/2021 |
| Date of final enrolment | 19/09/2022 |
Locations
Countries of recruitment
- France
Study participating centres
Levallois-Perret
92300
France
Libourne
33500
France
St Malo
35400
France
Vandoeuvre les Nancy
54500
France
Rillieux la Pape
69141
France
Amilly
45200
France
Sponsor information
Industry
41 rue de Neuilly
Nanterre
92735
France
| Phone | +33 (0)1.56.38.30.00 |
|---|---|
| service.accueil@brothier.com | |
| Website | http://www.brothier.com |
"ROR" |
https://ror.org/007jkh405 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. melanie.angot@brothier.com |
Editorial Notes
14/11/2022: The overall end date was changed from 14/11/2022 to 14/11/2023.
08/09/2021: Trial's existence confirmed by Sud-Est IV Ethics Committee
