Condition category
Surgery
Date applied
16/02/2015
Date assigned
23/02/2015
Last edited
09/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Louis-Etienne Gayet

ORCID ID

Contact details

CHU La Milétrie
Service de Chirurgie Orthopédique et Traumatologie
2 rue de la Milétrie
Poitiers
86000
France

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 measures

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

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

Sponsor information

Organisation

Brothier Laboratoires

Sponsor details

41 rue de Neuilly
Nanterre
92735
France

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes