Condition category
Surgery
Date applied
16/02/2015
Date assigned
23/02/2015
Last edited
23/02/2015
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 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof. Marc Revol

ORCID ID

Contact details

Hôpital Saint-Louis
Service de Chirurgie plastique
reconstructrice et esthétique
1 Avenue Claude Vellefaux
Paris
75010
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EXE-ALG/TPN-06.2013

Study information

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

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

French Ethics Committee (CPP Ile de France IV) 15/07/2013, ref 2013/22SC

Study design

Multicentre prospective randomised parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

02/07/2014

Overall trial end date

31/01/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

112

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

11/07/2014

Recruitment end date

31/12/2015

Locations

Countries of recruitment

France

Trial participating centre

Hôpital Croix Rousse
Lyon
69000
France

Trial participating centre

Hôpital Civil
Strasbourg
67000
France

Trial participating centre

Hôpital La Conception

Marseille
13000
France

Trial participating centre

Hôpital Saint-Roch
Nice
06000
France

Trial participating centre

CHU Angers

Angers
49000
France

Trial participating centre

Hôpital Hôtel Dieu

Nantes
44000
France

Trial participating centre

La Cavale Blanche
Brest
29000
France

Trial participating centre

CHU Lille
Lille
59000
France

Trial participating centre

CHU Bordeaux
Bordeaux
33000
France

Trial participating centre

Hôpital Saint-Louis
Paris
75010
France

Trial participating centre

Hôpital Saint-Antoine
Paris
75012
France

Trial participating centre

CHU Nancy
Nancy
54000
France

Trial participating centre

CHU Amiens
Amiens
80000
France

Trial participating centre

Hôpital Jean Minjoz
Besançon
25000
France

Trial participating centre

CHU Rennes
Rennes
35000
France

Sponsor information

Organisation

Laboratoires Brothier

Sponsor details

41
rue de Neuilly
Nanterre
92735
France

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Laboratoires Brothier

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 December 2016.

Intention to publish date

31/12/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes