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OpenTrials
Completed

NCT Number: NCT00527280

Face Reconstruction by Allotransplantation of Composite Tissues

To show the feasibility of face transplantation in patients

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital européen Geroges Pompidou

Paris, 75015, France

About this study

Most facial defects can be reconstructed with autologous tissues using standard plastic surgical techniques. However, when the circular facial muscles (eg. orbicularis oculi and orbicularis oris) are destroyed by burns, ballistic traumas, tumors, or congenital deformities there are no conventional surgical solutions. The study was designed following the advice of the French National Ethics Advisory Committee for life sciences and health (CCNE). The objectives are to study the feasibility and efficacy of face CTA transplantation, functional results, and influence on quality-of-life, as well as the management of immunosuppression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 through 65 years
  • Signed written informed consent
  • patient with a loss of substance of the median third of the face by traumatisms or not carrying the totality of the lips with or without the nasal pyramid.
  • validation of the feasibility by a committee of expert in plastic surgery and maxillofacial
  • patient with a positive psychologic evaluation
  • patient with an anatomical evaluation and assessment pretransplantation positive normal infectious assessment
  • Good compliance and capacity of adaptation to the assessment difficulties
  • Patient with renal, hepatic, hematologic ,cardiac normal
  • Patient profiting from a Social Security cover
  • Patient informed patient, having signed a free assent lit with inclusion in the study

Exclusion criteria

  • patient minor under supervision or deprived of freedom by court order or administrative.
  • person remaining in a medical or social establishment
  • pregnant. or breast-feeding women
  • patient presenting a sever cardiac pathology having a risk of decompensation into pre, per and post operational
  • patient presenting a hepatic pathology
  • Any cancer that has been in complete remission for > 5 years malignancies tumoral lesion of the face with 2 years deadline of remission respected renal insufficiency chronic clearance of creatin < 60l ml/mn
  • chronic respiratory insufficiency
  • patient presenting an active infection which can be worsened by the immunosuppression
  • patient presenting an active infection which can be worsened by the corticoid
  • patient with affection being able to compromise post-operative survival
  • patient with digestive ulcer
  • No known HIV infection
  • serology hepatitis B with circulating DNA highlighted quantitatively
  • personality emotional unstable
  • schizophrenic or not schizophrenic psychosis

Treatment and study plan

Feasibility ot face transplantation

Procedure

Feasibility ot face transplantation

Primary outcomes

  1. Reconstruction tissular at carrier patients of a loss of substance of the median third(third party) of the face having taken the totality of lips with or without the nasal pyramid; or of a loss of substance taking the totality of 4 eyelids.

    Time frame: during the study

Secondary outcomes

  1. To evaluate the potential benefit of such a transplantation in term of quality of life

    Time frame: during the study

  2. To measure the impact of this improvement

    Time frame: during the study

  3. To measure the impact of a immunosuppressive treatment for a pathology which is not vital

    Time frame: during the study

  4. To evaluate Acute Graft rejection using skin and mucosa biopsies: function of the lips and or eyelids mobility and function of the orbicularis muscles Quality of life the psychiatric and psychological evaluations

    Time frame: at in the following days weeks and month after surgery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2007
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.