- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02809001
The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
Descripción general del estudio
Descripción detallada
The repair of skin defects is a common problem for reconstructive surgeons.Soft tissue expansion is a widely used technique for the repair of skin defects. Early expansion-related complications such as skin thinning, telangiectasia, and striae may result in expansion failure and ultimately jeopardize final outcome. In the past years, discontinuation of the expansion procedure was the only therapeutic option, when early alarm signs such as semitransparent appearance and telangiectasia of the expanded skin were encountered. We aimed to overcome these complications by therapeutic fat grafting to prevent skin necrosis and enable continuation of the expansion procedure.
Patients undergoing soft tissue expansion treatment for resurfacing skin lesions including scars and nevi that required therapeutic intervention due to early complication signs were included in this study. Patients were randomly divided into treatment group using autologous fat grafting and control group with discontinued expansion and expectant management. The treatment group received autologous fat transfer to the expanded skin.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Shanghai, Porcelana
- Shanghai Ninth People's Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- Implanted silicone expander of 50 to 800 ml in size;
- History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- Persistent high level of expander internal pressure;
- Need for further skin expansion;
Exclusion Criteria:
- Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
- Rupture of expanded skin, expander exposure;
- Significant renal, cardiovascular, hepatic and psychiatric diseases;
- Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV);
- BMI less than 17 or insufficient subcutaneous fat;
- History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
- History of allogenic bone marrow transplantation;
- Pregnant or lactating woman;
- Long history of smoking;
- Evidence of malignant diseases or unwillingness to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Experimental: Fat grafting
Autologous fat graft transplantation subdermally to expanded skin.
|
In the experimental group, liposuction will be performed and autologous fat graft will be harvest after washing with saline.
Patients will receive autologous fat graft transplantation subdermally to expanded skin.
|
Sin intervención: Control
Expansion was discontinued until the early signs of complication disappeared.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To Measure the Change in Expansion Volume
Periodo de tiempo: Change from baseline volume at 12 weeks
|
Record the volume(ml) of each expander
|
Change from baseline volume at 12 weeks
|
To Measure the Change in Skin Thickness
Periodo de tiempo: Change from baseline skin thickness at 12 weeks
|
Record the thickness of the expanded skin(cm) by ultrasound scanning
|
Change from baseline skin thickness at 12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To Measure the Texture of Expanded Flap with VISIA scanner
Periodo de tiempo: baseline and 12 weeks post treatment
|
Evaluate skin texture with VISIA scanner and compare the characteristics
|
baseline and 12 weeks post treatment
|
Occurence of Major Adverse Events
Periodo de tiempo: Up to approximately 12 weeks after study start
|
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
|
Up to approximately 12 weeks after study start
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Shanghai9PH
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Nevo
-
University of California, DavisReclutamiento
-
Massachusetts General HospitalAún no reclutandoNevo melanocítico congénito
-
University Hospital, Basel, SwitzerlandTerminado
-
Manchester University NHS Foundation TrustNational Institute for Health Research, United KingdomTerminado
-
Albert ChiouNFlection Therapeutics, Inc.Aún no reclutandoNevos epidérmicos | Nevus sebáceoEstados Unidos
-
Russian Academy of Medical SciencesBlokhin's Russian Cancer Research CenterReclutamientoMelanoma | Nevo | Nevo Pigmentado | Melanoma (piel) | Melanoma de las mucosas | Lunares | Síndrome de nevus displásico | Nevus, Azul | Nevo, Spitz | Nevos, células fusiformes | Nevos Displásicos | Melanosis de la mucosaFederación Rusa
-
MelanomaPRO, RussiaPrivolzhsky Research Medical UniversityReclutamientoNevo | Nevo Pigmentado | Melanoma (piel) | Carcinoma de células basales | Carcinoma de células escamosas | Enfermedad de Bowen | Nevo, Spitz | Melanoma in situ | Nevus Halo | Punto pigmentadoFederación Rusa
-
National Cancer Institute (NCI)TerminadoNevos melanocíticos | Nevos melanocíticos adquiridos | Melanoma cutáneo primarioEstados Unidos
-
University of California, IrvineBeckman Laser Institute University of California IrvineRetirado
-
Ascend Biopharmaceuticals LtdSuspendidoCarcinoma de células basales en el síndrome de nevus de células basalesEstados Unidos
Ensayos clínicos sobre Fat grafting
-
Washington University School of MedicineAbbVieReclutamientoLinfoma difuso de células B grandesEstados Unidos
-
Lund UniversityFood for Health Science Centre, Lund UniversityTerminado
-
Malaysia Palm Oil BoardUniversiti Putra Malaysia; International Medical UniversityTerminado
-
University of AarhusRanders Municipality, Denmark; Aarhus KommuneTerminadoObesidad PediátricaDinamarca
-
Helsinki University Central HospitalTerminadoAlergia a las nuecesFinlandia