BurnPhase 3ENSEMNCT00774033
Epidermal Cells Delivery and Acute Burns
A Phase 3 study testing autologous epidermal cells harvesting kits and classic skin grafts in people with Burn, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burn
- What is being tested?
- autologous epidermal cells harvesting kits and classic skin grafts
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to May 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Thermal burns requiring surgical debridement
- Area involved < 1260cm²
Who cannot join
- local or systemic infection
- conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
- hypersensitivity to trypsin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Comparing Recell® Autologous Epidermal Cells Harvesting Kits Versus Classic Skin Grafts for the Treatment of Acute Burn in Adults and Children
The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns
Read the detailed description
Comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns.
Determine if the costs of the innovating treatment RECELL®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy.
Give an information about efficiency improvement of RECELL® with additional costs
- Conditions
- Burn
- Being tested
- autologous epidermal cells harvesting kits, classic skin grafts
- Keywords
- Keratinocytes, Cell spray, Deep partial thickness burns, Full thickness burns
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous epidermal cells harvesting kitsDevice
Also called Recell®
autologous epidermal cells harvesting kits used for the treatment of acute burn
classic skin graftsProcedure or surgery
classic skin grafts used for the treatment of acute burn
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment of acute burn in adults and children by epidermal cell spray Receives: Device: autologous epidermal cells harvesting kits |
| 2 | Active comparator | Treatment of acute burn in adults and children by classic skin grafts Receives: Procedure: classic skin grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.
Measured: at 1, 2 and 6 weeks
Secondary outcomes (4)
Medical costs at complete epithelialisation
Measured: At 6, 12 and 18 months
Post-operative pain
Measured: At 6 weeks
Medical assessment of scar quality
Measured: at 6 weeks and 6, 12, 18 months
Patient self assessment of scar
Measured: At 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2012
- Study completionMay 2012
Why it stopped: Not enough patients included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GALL, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774033
- Sponsor's protocol ID
- P070307
- Acronym
- ENSEM
- Status last verified
- Mar 2012
- First submitted
- 15 Oct 2008
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Recell® Autologous Epidermal Cells Harvesting Kits Versus Classic Skin Grafts for the Treatment of Acute Burn in Adults and Children
- ClinicalTrials.gov ID
- NCT00774033
- Acronym / sponsor ID
- ENSEM / P070307
- Conditions
- Burn
- Keywords
- Keratinocytes, Cell spray, Deep partial thickness burns, Full thickness burns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients included
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns
Detailed description
Comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns.
Determine if the costs of the innovating treatment RECELL®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy.
Give an information about efficiency improvement of RECELL® with additional costs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: autologous epidermal cells harvesting kitsTreatment of acute burn in adults and children by epidermal cell spray |
| 2 | Active comparator | Procedure: classic skin graftsTreatment of acute burn in adults and children by classic skin grafts |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Thermal burns requiring surgical debridement
- Area involved < 1260cm²
Key exclusion criteria (3 listed)
- local or systemic infection
- conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
- hypersensitivity to trypsin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous epidermal cells harvesting kitsAlso: Recell®autologous epidermal cells harvesting kits used for the treatment of acute burn | Device | 1 |
| classic skin graftsclassic skin grafts used for the treatment of acute burn | Procedure or surgery | 2 |
Primary outcome
80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.
Time frame: at 1, 2 and 6 weeks
4 secondary outcomes
Medical costs at complete epithelialisation
Time frame: At 6, 12 and 18 months
Post-operative pain
Time frame: At 6 weeks
Medical assessment of scar quality
Time frame: at 6 weeks and 6, 12, 18 months
Patient self assessment of scar
Time frame: At 6, 12 and 18 months
Results and safety
The study was stopped early (reason given: Not enough patients included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier GALL, PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing autologous epidermal cells harvesting kits and classic skin grafts in people with Burn, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not enough patients included). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks. (time frame: at 1, 2 and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.