Comparison of the efficacy, tolerance and cost of Algostéril vs Negative Pressure Therapy in preparation for skin grafting following surgical excision
| ISRCTN | ISRCTN60292377 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60292377 |
| Secondary identifying numbers | EXE-ALG/TPN-06.2013 |
- Submission date
- 16/02/2015
- Registration date
- 23/02/2015
- Last edited
- 08/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 how to compare the Algosteril product to negative-pressure wound therapy in preparation for skin grafting following surgical excision.
Who can participate?
Adults scheduled for surgical removal with a granulation phase (a phase of the wound healing process) before a skin graft.
What does the study involve?
Participants will be randomly allocated to one of two groups: NPWT or Algosteril.
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 Hopital St Louis, Paris.
When is the study starting and how long is it expected to run for?
From July 2014 to December 2015
Who is funding the study?
Laboratoires Brothier (France)
Who is the main contact?
Sandra Kolb
kolb@brothier.com
Contact information
Scientific
Hôpital Saint-Louis
Service de Chirurgie plastique, reconstructrice et esthétique
1 Avenue Claude Vellefaux
Paris
75010
France
Study information
| Study design | Multicentre prospective randomised parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Comparison of the efficacy, tolerance and cost of Algostéril vs Negative Pressure Therapy in preparation for skin grafting following surgical excision: a multicentre prospective randomised parallel group trial |
| Study acronym | ATEC |
| Study hypothesis | The granulation phase can be supported by medical devices including Algosteril and Negative Pressure Therapy which are most commonly used, with good results. The study will demonstrate the non-inferiority of both treatments to obtain an optimal granulation tissue to receive a thin skin graft. |
| Ethics approval(s) | French Ethics Committee (CPP Ile de France IV) 15/07/2013, ref 2013/22SC |
| Condition | Surgical removal with a granulation phase before a skin graft supported in restorative, reconstructive and plastic surgery service |
| Intervention | Surgical excision of the skin and underlying tissues are carried out in plastic surgery for tumor traumatic or infectious causes. If the resulting defect is well vascularized, it can be covered by a thin skin graft immediately or just after after a granulation phase. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time to optimal granulation. After excision, evaluation for grafting every 7 days and until the wound can receive skin graft. |
| Secondary outcome measures | 1. Care costs: at each dressing change 2. Patient quality of life: every 7 days and until the wound can receive skin graft. 3. Tolerance: thought the trial |
| Overall study start date | 02/01/2013 |
| Overall study end date | 10/09/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 112 |
| Total final enrolment | 95 |
| Participant inclusion criteria | 1. Written informed consent 2. Patients aged 18 years or older 3. Scheduled for surgical removal with a granulation phase before a skin graft |
| Participant exclusion criteria | 1. Uncontrolled hyperglycemia 2. Excision is secondary to burns 3. Treated within 30 days before enrollment with immunosuppressants, chemotherapy, radiotherapy on the site excised, |
| Recruitment start date | 02/07/2014 |
| Recruitment end date | 30/06/2016 |
Locations
Countries of recruitment
- France
Study participating centres
69000
France
67000
France
13000
France
06000
France
49000
France
44000
France
29000
France
59000
France
33000
France
75010
France
75012
France
54000
France
80000
France
25000
France
35000
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 | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | All study results will be published in the same publication. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Marc Revol (mrevol05@gmail.com). Type of data : Individual participant data that underlie the results reported in the article after anonymisation and the study protocol When the data will become available and for how long: Beginning 9 months and ending 36 months following article publication By what access criteria data will be shared including with whom: To investigators whose proposed use of the data has been approved by the corresponding author and the sponsor For what types of analyses: Meta-analysis By what mechanism: Proposals should be directed to the corresponding author (mrevol05@gmail.com) up to 36 months following article publication. To gain access, data requestors will need to sign a data access agreement. An accessing data link will be created to recipients Whether consent from participants was obtained: Consent from participants was obtained and restricts the data access to the French health authorities Comments on data anonymization: Data were anonymized (Patient number from 1 to 113) Ethical or legal restrictions: From 2018, the EU General Data Protection Regulation (GDPR) restricts transfers of personal data to countries outside the EEA. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 31/07/2019 | 21/07/2021 | No | No | |
| Results article | 27/03/2020 | 08/03/2023 | Yes | No |
Additional files
Editorial Notes
08/03/2023: Publication reference and total final enrolment added.
21/07/2021: Internal review.
03/09/2019: IPD sharing statement added.
31/07/2019: The following changes were made to the trial record:
1. The basic results of this trial have been uploaded as an additional file.
2. The intention to publish date was changed from 31/12/2017 to 31/12/2020.
02/07/2019: Internal review.
26/01/2017: The overall trial dates have been updated from 02/07/2014 - 31/01/2016 to 02/01/2013 - 01/09/2016 and the recruitment dates have been updated from 11/07/2014 - 31/12/2015 to 02/07/2014 - 30/06/2016.
