Healing efficacy, safety and ease of use of a thin Algostéril
| ISRCTN | ISRCTN38373718 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38373718 |
| Secondary identifying numbers | N°ID RCB : 2016-A00101-50 |
- Submission date
- 11/01/2017
- Registration date
- 19/01/2017
- Last edited
- 08/08/2018
- 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
Patients with open wounds often need to be treated with a dressing to help the wound to heal. 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 is looking at a new form of Algosteril, narrower than Algosteril, commonly used by surgeons. The aim of this study is to find out whether this new shape of Algosteril, which can better adapt to the shape of wounds, can help improve wound healing.
Who can participate?
Adults with a wound that needs dressing.
What does the study involve?
Each patient is treated using Algostéril dressings until their wound is healed. The dressing is replaced when required (every two days maximum) until it is no longer required. The length of wound healing is around one month, however this may vary depending on the patient. The wound is examined every time the dressing is changed in order to look for any signs of infection and to record the length of time taken for the wound to heal.
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. There are no notable risks involved with participating in this study.
Where is the study run from?
1. Pitié-Salpêtrière Hospital (France)
2. CHU Estaing (France)
3. Centre François-Xavier Michelet (France)
4. Jean Minjoz Hospital (France)
When is the study starting and how long is it expected to run for?
February 2016 to December 2017
Who is funding the study?
Les 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 | Multi-centre prospective non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Healing efficacy, safety and ease of use of a thin Algostéril in the wounds of maxillofacial surgery |
| Study objectives | The aim of the study is to demonstrate the efficiency of thin Algostéril in wounds of the head and the neck. |
| Ethics approval(s) | Persons Protection Committee, CPP Ile-De-France VI, 16/03/2016, ref: CPP/7-16 |
| Health condition(s) or problem(s) studied | Wound care |
| Intervention | All patients have their wounds treated using an Algostéril dressing until wound healing (about one month). Wounds will be redressed every two days maximum. Participants are clinically examined in order to determine the number of days until wound healing occurs. There will be no follow up post-healing. |
| Intervention type | Other |
| Primary outcome measure | Number of days of treatment to obtain the wound healing is assessed through clinical examination until time of wound healing (approximately 1 month). |
| Secondary outcome measures | 1. Draining efficiency evaluated by exsudate quantity and local signs of infection at the time of redressing (every 2 days maximum) 2. Ease of use is assessed using a scale of 1 to 4 at the time of redressing (every 2 days maximum) 3. Safety is assessed by recording the type and frequency of adverse events continuously throughout the study |
| Overall study start date | 01/02/2016 |
| Completion date | 31/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Patients with a wound that needs to be treated with thin Algostéril 2. Those who can be followed until the wound healing 3. Signed informed consent form 4. Aged 18 years and over |
| Key exclusion criteria | 1. Pregnant women 2. Participation in another clinical trial within 30 days prior to inclusion |
| Date of first enrolment | 16/01/2017 |
| Date of final enrolment | 30/04/2019 |
Locations
Countries of recruitment
- France
Study participating centres
Paris
75013
France
Clermont-Ferrand
63100
France
Bordeaux
33076
France
Besançon
25030
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 | 31/03/2020 |
|---|---|
| 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 | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
08/08/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 01/03/2018 to 31/05/2019
2. The recruitment end date has been changed from 30/06/2018 to 30/04/2019
3. The intention to publish date has been changed from 31/03/2019 to 31/03/2020
30/01/2018: The recruitment end date has been updated from 31/12/2017 to 30/06/2018. The overall trail end date has been updated from 31/03/2018 to 01/03/2019.
