Giant congenital melanocytic nevi
Conditions
Interventions
Intervention type:DEVICE
Name of intervention:Cultured epithelial autografts (CEA)
Dose form / Japanese Medical Device Nomenclature:DEVICE
Human cultured epithelial autografts
Route of administration
Sponsors
Tsuyoshi Kaneko, MD, Plastic Surgery, National Center for Child Health and Development
Masaki Aihara, MD, Plastic Surgery, St. Marianna University School of Medicine Hospital
Hirotaka Asato, MD, Plastic Surgery, Dokkyo Medical University Hospital
Keisuke Imai, MD, Plastic and Reconstructive Surgery, Osaka City General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The patient with giant congenital melanocytic nevi 2.The giant congenital melanocytic nevi cover approximately 5 % or greater of the body surface area. 3.The patient is the age of 3 months or older at the time of CEA grafting.
Exclusion criteria
Exclusion criteria: 1.The patient with hypersensitivity to penicillin, kanamycin, streptomycin, amphotericin B and/or the patient has a history of hypersensitivity to penicillin antibiotic and aminoglycoside antibiotic 2.The patient has an allergy to cattle, mice and/or swine 3.The patient with cutaneous malignant tumor, the patient suspected of cutaneous malignat tumor, the patient has a history of cutaneous malignant tumor 4.The patient has an experience with CEA 5.The patient participated in other clinical trials in the past 30 days, the patient will or may participate other clinical trials during the trial. 6.The patient who is considered ineligible by the principal investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The case that epithelialization rate is 95% or greater after CEA grafting without any other treatments is evaluated as 'effective'. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Epithelialization rate at 8th week and 12th week after first CEA grafting 2.Final epithelialization rate after CEA grafting. 3.Number of days between first CEA grafting and completing epithelialization 4.Length of hospital stay (from first CEA grafting to permission for discharge) | — |
Countries
Japan
Contacts
Public ContactNanako Nagafuchi
National Center for Child Health and Development
Outcome results
None listed