Plain English Summary
Background and study aims
Negative-pressure wound therapy (NPWT) is a technique which uses a vacuum dressing to promote healing in acute or chronic wounds. The aim of this study is to compare two treatment sequences involving Algosteril.
Who can participate?
Adults treated by NPWT for 7 days and who need to be treated by NPWT for another 4 days minimum. They must be able to self-assess their pain.
What does the study involve?
Participants will be randomly allocated to one of two sequences:
Sequence A = Treatment at day 0 = Foam + Algostéril; Treatment at day 2 = Foam only
Sequence B : Treatment at day 0 = Foam only; Treatment at day 2 = Foam + Algostéril
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
A number of French hospitals. The lead centre is CHU La Milétrie, Poitiers (France).
When is the study starting and how long is it expected to run for?
From October 2014 to April 2015
Who is funding the study?
Laboratoires Brothier (France)
Who is the main contact?
Mélanie Angot
angot@brothier.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2014-A00247-40
Study information
Scientific title
A randomized clinical trial assessing the pain when withdrawal of Negative Pressure Wound Therapy: Algostéril + Foam vs Foam only
Acronym
Study hypothesis
Demonstrate that pain is alleviated by Algostéril.
Ethics approval
French Ethics Committee (Comité de Protection des Personnes Ouest III), 02/06/2014.
French Drug Administration (Agence Nationale de Sécurité du Médicament), 11/04/2014.
Protocol N°14.03.18.
Study design
Multicentre prospective randomized cross-over study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Patient with loss of wound exudate that needs to be treated with Negative Pressure Wound dressing.
Intervention
After 7 days of Negative Pressure Wound dressing, randomisation is performed in a 1:1 ratio allocation.
According to the randomisation sequence, patient has to be treated with Algostéril + Foam during 2 days then he/she has to be treated with the foam only during 2 days or patient has to be treated with the foam only during 2 days then he/she has to be treated with Algostéril + foam during 2 days.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Assessment of pain using a scale from 0 to 10 at day 2 and day 4
Secondary outcome measures
1. Assessment of bleeding with a 5-level scale - day 2 and day 4
2. Quantity of exudate in the Negative Pressure Wound Dressing reservoir - day 2 and day 4
3. Assesment of safety - throughout the trial
Overall trial start date
07/10/2014
Overall trial end date
07/04/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Who have wound exudate treated with Negative Pressure Therapy for 7 days and whose treatment with Negative-Pressure Wound Therapy with black foam and without instillation needs to be continued for a minimum of 4 days
3. Able to self-assess pain
4. Can be followed during the 4 days of the study
5. Signed informed consent form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
32
Participant exclusion criteria
1. Exudate resulting from a burn
2. Under analgesic level III
3. With known diabetic neuropathy
4. Negative-Pressure Wound Therapy which is contraindicated according to Haute Autorité de Santé (HAS) recommendations
5. Participant or participating in another clinical trial within 30 days prior to inclusion
Recruitment start date
07/10/2014
Recruitment end date
07/04/2015
Locations
Countries of recruitment
France
Trial participating centre
CHU La Milétrie
Poitiers
86021
France
Trial participating centre
Hôpital Saint Louis
Paris
75475
France
Trial participating centre
CHU Hôpital Jean Minjoz
Besançon
25000
France
Trial participating centre
CHU La Rochelle-Ré-Aunis
17019
France
Trial participating centre
CHU Amiens - Picardie
Amiens
80054
France
Trial participating centre
CHU Hôpital Central
Nancy
54035
France
Trial participating centre
Hôpital Avicenne
Bobigny
93000
France
Trial participating centre
Centre Hospitalier du Pays d'Aix
Aix en Provence
13617
France
Funders
Funder type
Industry
Funder name
Brothier Laboratoires
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 in 05/2016.
Intention to publish date
31/05/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list