A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane

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Brief Title

A Comparative Study of the Healing of Chronic Ulcers of Recessive Epidermolysis Bullosa : Dressing vs Amniotic Membrane

Official Title

A Comparative Study of the Healing of Chronic Skin Ulcers of Recessive Dystrophic Epidermolysis Bullosa : Standard Dressing Versus Amniotic Membrane.

Brief Summary

      Skin wounds of Recessive Epidermolysis Bullosa Dystrophica (REBD) involve pain,
      superinfection, protein-losing, inflammation, and joint contractures are the bed of squamous
      cell carcinoma. There is no precise data on the kinetics of healing post-bullous erosions but
      clinical experience suggests that most epidermise in less than a month. Some, however, for
      unknown reasons, persist for several months. These chronic ulcers (UC), arbitrarily defined
      for this study as lasting more than three months are a source of major discomfort and could
      play a decisive role in the morbidity and mortality of the disease.

      The aim of this study is to evaluate the efficacy of the amniotic membrane on the healing of
      chronic ulcers REBD on the percentage ulcerated surface re-epithelialised at 12 weeks (M3)
      from the start of treatment.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Percentage of ulcerated area re-epithelialised


Condition

Epidermolysis Bullosa Dystrophica, Recessive

Intervention

Amniotic Membrane

Study Arms / Comparison Groups

 Standard Dressing
Description:  J0 to J42 : once a week, primary dressing with Mepitel®

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

22

Start Date

January 2015

Completion Date

January 2020

Primary Completion Date

January 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Age between 2 years and 60

          -  REBD clinically evident with immunohistological confirmation and / or genetic

          -  REBD with at least two chronic ulcers (> 3 months) comparable

          -  Signing the informed consent of the patient and / or (children) of parents holding
             parental authority

          -  Affiliation to a social security scheme (beneficiary or legal)

        Exclusion Criteria:

          -  Epidermoid carcinoma on the target or chronic ulcers

          -  Budding excessive requiring the application of a topical corticosteroid on the target
             or chronic ulcers

          -  Skin bacterial superinfection clinically overt requiring oral antibiotics

          -  Herpes simplex virus superinfection

          -  major evolutionary and malnutrition defined as a BMI <12 or more than 2 variant
             between screening and randomization OR a serum albumin <20 g / l or more ranging from
             5 g / l between screening and randomization

          -  major and progressive anemia defined by a Hb <6 g / liter or variant more than 4 g / l
             between screening and randomization

          -  Life expectancy estimated at less than 3 months

          -  Pregnancy

          -  Inability to understand or observance of the rules of protocol

          -  Participation in another interventional therapeutic biomedical research whose
             treatment is not yet completed or the primary endpoint is not yet measured at the time
             of inclusion in Mabul
      

Gender

All

Ages

2 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, 142499742, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02286427

Organization ID

P130907 - 2014-001805-42


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

, , 


Verification Date

November 2016