Intentional Self Harm by Other Specified Means, Soft Tissue Infections
Conditions
Keywords
Self-regeneration, in vivo tissue prefabrication,
Brief summary
The purpose of this study is to observe the feasibility and its application of autologous prefabrication for body surface tissues/oranges
Detailed description
In the field of tissue regeneration techniques, the in vitro processes and other exogenous factors still have many uncertainties. These uncertainties have hampered road to the clinical application. As the importance of in vivo environment has aroused more awareness, the investigators validated the hypothesis that the feasibility of self-regeneration prefabricated unaided by any in vitro culture process or exogenous elements.
Interventions
PROCEDUREtissue/ organ prefabrication
tissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* With body surface tissue or organ defects (e.g., ear, nose, bone and joint) requiring reconstruction.
Exclusion criteria
* evidence of infection, ischemia, ulcer or other pathological changes within the prefabricated area which defined as not suitable for tissues regeneration * history of delayed healing, radiational therapy; * 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 \>30; * history of any hematological disease, including leukopenia, thrombocytopenia, or thrombocytosis; * Evidence of malignant diseases * unwillingness to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of major adverse events | through study completion 12 months after prefabrication | Including infection, necrosis, resorption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of self-prefabrication | 3, 6, and 12 months after prefabrication | To observe the regeneration changes of prefabricated neo-tissue by histology (staining) and biomechanical analysis (bone density, Young's modulus) |
Other
| Measure | Time frame | Description |
|---|---|---|
| survival of prefabricated tissue after grafting | 3, 6, 12, and 36 months after grafting | Assessed by radiologic imaging (CT, MRT) |
| biomechanical function of prefabricated tissue after grafting | 3, 6, 12, and 36 months after grafting | Assessed by total range of motion (degree) |
Countries
China
Outcome results
None listed