Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N°ID RCB : 2016-A00101-50
Study information
Scientific title
Healing efficacy, safety and ease of use of a thin Algostéril in the wounds of maxillofacial surgery
Acronym
Study hypothesis
The aim of the study is to demonstrate the efficiency of thin Algostéril in wounds of the head and the neck.
Ethics approval
Persons Protection Committee, CPP Ile-De-France VI, 16/03/2016, ref: CPP/7-16
Study design
Multi-centre prospective non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/02/2016
Overall trial end date
01/03/2018
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Pregnant women
2. Participation in another clinical trial within 30 days prior to inclusion
Recruitment start date
16/01/2017
Recruitment end date
30/06/2018
Locations
Countries of recruitment
France
Trial participating centre
Pitié-Salpêtrière Hospital
47-83 Boulevard de l'Hôpital
Paris
75013
France
Trial participating centre
CHU Estaing
1 Rue Lucie Aubrac
Clermont-Ferrand
63100
France
Trial participating centre
Centre François-Xavier Michelet
Place Amélie Raba-Léon
Bordeaux
33076
France
Trial participating centre
Jean Minjoz Hospital
3 Boulevard A. Fleming
Besançon
25030
France
Funders
Funder type
Industry
Funder name
Les Laboratoires Brothier
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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.
Intention to publish date
31/03/2019
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary