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BurnsPhase 2NCT00366041

Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries

A Phase 2 study testing Dermal substrate cellularised LG002 (10x10cm) and Dermal substrate uncellularised LG002 (10x10 cm) in people with Burns, run by Laboratoires Genévrier at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

After severe burn injury, the full-thickness burn areas are excised (in the first week) and then temporarily covered with allograft (cryogenic preserved cadaver skin). This first covering is then replaced with thin skin meshed autograft. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Burns
What is being tested?
Dermal substrate cellularised LG002 (10x10cm) and Dermal substrate uncellularised LG002 (10x10 cm)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesFrance
Study dates
Feb 2006to Dec 2009
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with severe burn injuries ≥ 40 % of TBSA (Total Body Surface Area)
  • Thermal burn on symmetrical areas allowing grafting of 4 contiguous dermal substrates (cellularised LG002 or uncellularised LG002) on each area
  • The patient himself, or his legal representative, must give his informed consent in writing

Who cannot join

  • Anterior progressive serious illness (i.e severe hepatic insufficiency, immunodepression induced by corticotherapy or illness (AIDS))
  • Metabolic disease
  • Systemic infection or local burn infection
  • Known allergy to collagen, streptomycin, Penicillin and/or bovine origine products

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Hôpital d' Instruction des Armées de Percy, Service des Brûlés

    Clamart, 92141

  • Hôpital Cochin, Service des Brûlés

    Paris, 75679

Other trials in France

About this study

Official title: Multicentre Clinical Study to Compare the Efficacy and the Tolerance of Cellularised LG002 With the Efficacy and Tolerance of Uncellularised LG002 in the Treatment of Severe Burn Injury

After severe burn injury, the full-thickness burn areas are excised (in the first week) and then temporarily covered with allograft (cryogenic preserved cadaver skin). This first covering is then replaced with thin skin meshed autograft.

In this study, either the dermal substrates cellularised LG002 or uncellularised LG002 will be grafted, after excision, in symmetrical areas, in replacement of the allografts. Fourteen to twenty one days after this first covering, the dermal substrate will be covered with thin skin meshed autograft.

Read the detailed description

For lesions that cannot heal spontaneously, the wound is excised until fascia. Four contiguous dermal substrates (uncellularised and cellularised) are randomly grafted on each symmetric area.

A primary siliconized dressing will cover the wound. Secondary dressing: dressing gauze impregnated with physiologic serum and/or sterile dried dressing gauze, the whole is maintained by a (slightly compressive) tubular or elastic bandage.

Thin skin meshed autograft will occur 14 to 21 days after dermal substrate cellularised LG002 or uncellularised LG002 grafting (time frame necessary for the site to vascularize).

Meshed autograft development must be identical in both symmetric areas, for one single patient.

Conditions
Burns
Being tested
Dermal substrate cellularised LG002 (10x10cm), Dermal substrate uncellularised LG002 (10x10 cm)
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dermal substrate cellularised LG002 (10x10cm)Drug

    application depending on burn injury surface

  • Dermal substrate uncellularised LG002 (10x10 cm)Device

    depending on burn injury surface

Study groups in NCT00366041
Study groupRoleWhat they receive
Cellularised LG002ExperimentalCellularised LG002
Receives: Drug: Dermal substrate cellularised LG002 (10x10cm)
UnCellularised LG002ExperimentalUnCellularised LG002
Receives: Device: Dermal substrate uncellularised LG002 (10x10 cm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of take of thin skin autografts 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002 (visual assessment + photography)

    Measured: 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002

Secondary outcomes (4)

  1. Short and medium term: Percentage of take of thin skin autografts 12 and 30 days after their application

    Measured: 12 and 30 days after their application

  2. Long term: Clinical evaluation (Vancouver scale 1, 3, 6, 12 months) and histological evaluation (3mm biopsy) to investigate the dermal-epidermal junction and the extra-cellular matrix (1 and 6 month) in order to evaluate the scar quality

    Measured: 1, 3, 6, 12 months

  3. Tolerance parameter: Investigator's global judgement, post grafting infection (swabbing during each new dressing for staphylococcus aureus detection), adverse event for intolerance

    Measured: each application

  4. Supplementary parameter: Allogenic fibroblasts survival : chimerism study with biopsy (1 and 6 months)

    Measured: 1 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionDec 2008
  4. Study completionDec 2009

Why it stopped: not appropriate to carry on the study

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00366041
Sponsor's protocol ID
03F/DE01
Status last verified
Jan 2010
First submitted
17 Aug 2006
Last updated
21 Jan 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Berthod F, Saintigny G, Chretien F, Hayek D, Collombel C, Damour O. Optimization of thickness, pore size and mechanical properties of a biomaterial designed for deep burn coverage. Clin Mater. 1994;15(4):259-65. doi: 10.1016/0267-6605(94)90055-8.

    PubMed 10147169

  • Damour O, Gueugniaud PY, Berthin-Maghit M, Rousselle P, Berthod F, Sahuc F, Collombel C. A dermal substrate made of collagen--GAG--chitosan for deep burn coverage: first clinical uses. Clin Mater. 1994;15(4):273-6. doi: 10.1016/0267-6605(94)90057-4.

    PubMed 10147171

  • Coulomb B, Lebreton C, Dubertret L. Influence of human dermal fibroblasts on epidermalization. J Invest Dermatol. 1989 Jan;92(1):122-5. doi: 10.1111/1523-1747.ep13071335.

    PubMed 2909624

  • Berthod F, Hayek D, Damour O, Collombel C. Collagen synthesis by fibroblasts cultured within a collagen sponge. Biomaterials. 1993 Aug;14(10):749-54. doi: 10.1016/0142-9612(93)90039-5.

    PubMed 8218724

  • Froget S, Barthelemy E, Guillot F, Soler C, Coudert MC, Benbunan M, Dosquet C. Wound healing mediator production by human dermal fibroblasts grown within a collagen-GAG matrix for skin repair in humans. Eur Cytokine Netw. 2003 Jan-Mar;14(1):60-4.

    PubMed 12799215

  • Saintigny G, Bonnard M, Damour O, Collombel C. Reconstruction of epidermis on a chitosan cross-linked collagen-GAG lattice: effect of fibroblasts. Acta Derm Venereol. 1993 Jun;73(3):175-80. doi: 10.2340/0001555573175180.

    PubMed 8105612

  • Sher SE, Hull BE, Rosen S, Church D, Friedman L, Bell E. Acceptance of allogeneic fibroblasts in skin equivalent transplants. Transplantation. 1983 Nov;36(5):552-7. doi: 10.1097/00007890-198311000-00015.

    PubMed 6356519

  • Braye FM, Stefani A, Venet E, Pieptu D, Tissot E, Damour O. Grafting of large pieces of human reconstructed skin in a porcine model. Br J Plast Surg. 2001 Sep;54(6):532-8. doi: 10.1054/bjps.2001.3620.

    PubMed 11513518

  • Coulomb B, Friteau L, Baruch J, Guilbaud J, Chretien-Marquet B, Glicenstein J, Lebreton-Decoster C, Bell E, Dubertret L. Advantage of the presence of living dermal fibroblasts within in vitro reconstructed skin for grafting in humans. Plast Reconstr Surg. 1998 Jun;101(7):1891-903. doi: 10.1097/00006534-199806000-00018.

    PubMed 9623833

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dermal substrate cellularised LG002 (10x10cm) and Dermal substrate uncellularised LG002 (10x10 cm) in people with Burns, run by Laboratoires Genévrier at 2 sites 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 3 inclusion and 4 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 21 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 appropriate to carry on the study). 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?

Percentage of take of thin skin autografts 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002 (visual assessment + photography) (time frame: 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00366041, which also lists 9 linked publications.

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 21 Jan 2010.

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