Condition category
Skin and Connective Tissue Diseases
Date applied
11/01/2017
Date assigned
19/01/2017
Last edited
30/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Maryse Mueser

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 : 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 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 trial start date

01/02/2016

Overall trial end date

01/03/2018

Reason abandoned (if study stopped)

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

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

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.