Assessment of pain when withdrawal of Negative Pressure Wound Therapy: Algostéril + Foam vs Foam only
| ISRCTN | ISRCTN16353157 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16353157 |
| Secondary identifying numbers | 2014-A00247-40 |
- Submission date
- 16/02/2015
- Registration date
- 23/02/2015
- Last edited
- 09/10/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
CHU La Milétrie
Service de Chirurgie Orthopédique et Traumatologie
2 rue de la Milétrie
Poitiers
86000
France
Study information
| Study design | Multicentre prospective randomized cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomized clinical trial assessing the pain when withdrawal of Negative Pressure Wound Therapy: Algostéril + Foam vs Foam only |
| Study objectives | Demonstrate that pain is alleviated by Algostéril. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 07/10/2014 |
| Completion date | 07/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 32 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/10/2014 |
| Date of final enrolment | 07/04/2015 |
Locations
Countries of recruitment
- France
Study participating centres
86021
France
75475
France
25000
France
France
80054
France
54035
France
93000
France
13617
France
Sponsor information
Industry
41 rue de Neuilly
Nanterre
92735
France
"ROR" |
https://ror.org/007jkh405 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/05/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | All study results will be published in the same publication in 05/2016. |
| IPD sharing plan |
