- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02809001
The Effects of Autologous Fat Transfer on Preventing Expanded Skin From Expansion Failure
Panoramica dello studio
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Luoghi di studio
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Shanghai, Cina
- Shanghai Ninth People's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Experimental: Fat grafting
Autologous fat graft transplantation subdermally to expanded skin.
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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.
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Nessun intervento: Control
Expansion was discontinued until the early signs of complication disappeared.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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To Measure the Change in Expansion Volume
Lasso di tempo: Change from baseline volume at 12 weeks
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Record the volume(ml) of each expander
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Change from baseline volume at 12 weeks
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To Measure the Change in Skin Thickness
Lasso di tempo: Change from baseline skin thickness at 12 weeks
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Record the thickness of the expanded skin(cm) by ultrasound scanning
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Change from baseline skin thickness at 12 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
To Measure the Texture of Expanded Flap with VISIA scanner
Lasso di tempo: baseline and 12 weeks post treatment
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Evaluate skin texture with VISIA scanner and compare the characteristics
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baseline and 12 weeks post treatment
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Occurence of Major Adverse Events
Lasso di tempo: Up to approximately 12 weeks after study start
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Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
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Up to approximately 12 weeks after study start
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- Shanghai9PH
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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