The Dermisgraft Epithelialization and Late Scar Healing
A Prospective Multi-centre Randomised Study for Treatment of Burns With Dermis Graft or Split-thickness Skin Auto-graft.
Study Synopsis
Title; The dermis graft: epithelialization and late scar evaluation A Clinical Prospective multicenter trial
Objectives; The objective of this study is to compare a dermal graft with a conventional split thickness skin graft regarding healing quality and scarring.
Design; the study is a prospective, controlled clinical multicenter trial.
Study population; Atleast 20 burn patients (18-80 years) with a full thickness burn that requires permanent skin cover.
Time plan; Enrollment will continue until atleast 20 patients have been included and completed the study.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Donor site morbidity is a major concern such as wound healing disturbances, hypertrophic scarring and hypo-/hyperpigmentation. The dermal graft technique is an alternative to the standard split-thickness skin graft (STSG) technique to minimize donor site morbidity. Immediate cover of the donor site after harvest leaving a non-exposed wound is a big advantage. The aim of the study was to compare the functional and aesthetic outcome between two treatment methods (dermal graft with STSG).
Methods: From February 2017 to December 2020, 21 patients received a dermis graft and a regular split-thickness skin graft in a prospective randomized study design. The recipient and the donor site were compared separately regarding healing time, scarring and patient subjective satisfaction. All sites (both donor and recipient) were analyzed histologically regarding remodeling and scar formation.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Linköping, Suecia
- Linköpings Unversity Hospital
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Thermal & chemical burns < 30 % TBSA
- Males & females between 18-80 years old
- At least one coherent full thickness wound measuring 15 x 7.5 cm
- A minimal of 15 x 7.5 cm coherent undamaged skin located at frontal or lateral side of one of the thighs for graft harvest.
Exclusion Criteria:
- Patients with severe cutaneous trauma at the same site as the burn injury
- Previous burns at the treatment site
- Severe cognitive dysfunction or psychiatric disorder
- Chronic skin disorder
- Chronic use of systemic or local corticosteroid
- Chronic use of anticoagulants or platelets
- Autoimmune disease
- Active hepatitis
- Full thickness burns of head, genitalia, axilla or upper third of medial upper arm
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Dermis graft
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The study compare two different treatment modalities, STSG (split-thickness skin graft) versus dermis graft after excision of devitalized/necrotic tissue. A dermatome will be used for graft harvest. |
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Experimental: STSG
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The study compare two different treatment modalities, STSG (split-thickness skin graft) versus dermis graft after excision of devitalized/necrotic tissue. A dermatome will be used for graft harvest. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Healing time
Periodo de tiempo: 4 weeks
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Recipient sites are to be assessed regarding healing (re-epithelization) at each site (donor respective recipient).
Healing will be assesed in days after surgery.
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4 weeks
|
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Aesthetic outcome
Periodo de tiempo: 12 months
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The aesthetic appereance regarding scarring will be assessed. A MPA580 cutometer will asses the viscoelasticity in the skin and POSAS will asses the appereance of the scar objectively as subjectively. R0 and R2 will be used as variables evaluating firmness and elasticity. POSAS will be analysed accoring to a scoring system (0-10 and 0-60). |
12 months
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2.4
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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