Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/01/2016
Date assigned
06/01/2016
Last edited
05/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Mueser Maryse

ORCID ID

Contact details

Les laboratoires Brothier
41 rue de Neuilly
Nanterre
92735
France

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

Phase

Drug names

Primary outcome measures

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

04/12/2015

Reason abandoned

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

Sponsor information

Organisation

Les laboratoires Brothier

Sponsor details

41 rue de neuilly
Nanterre
92735
France

Sponsor type

Industry

Website

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

Intention to publish date

31/12/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes