Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2020-10-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Stem cell group
autologous adipose stem cell injection
Abdominal or buttock fat will be aspirated under local anesthesia or general anesthesia by conventional methods (0.5 ml fat was aspirated per 1 cm2 of skin graft area). The matrix component rich in adipose stem cells will be obtained by chopping, washing and centrifugation. The intervention treatment will be performed after the skin graft sutured. The stem cell components will be injected underneath the skin graft (0.05 ml/cm2).
Control
saline injection
saline will be injected underneath skin graft (0.05 ml/cm2).
Interventions
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autologous adipose stem cell injection
Abdominal or buttock fat will be aspirated under local anesthesia or general anesthesia by conventional methods (0.5 ml fat was aspirated per 1 cm2 of skin graft area). The matrix component rich in adipose stem cells will be obtained by chopping, washing and centrifugation. The intervention treatment will be performed after the skin graft sutured. The stem cell components will be injected underneath the skin graft (0.05 ml/cm2).
saline injection
saline will be injected underneath skin graft (0.05 ml/cm2).
Eligibility Criteria
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Inclusion Criteria
2. Gender: male and female;
3. Scar, surface tumor or soft tissue defect evaluated to be suitable for skin grafting;
4. With two skin grafting areas and the edges more than 4cm apart;
5. Sign informed consent, participate in the study and be able to cooperate with the follow-up.
Exclusion Criteria
2. There who are with local lesions in the operation area, such as infection, blood supply disturbance, delayed healing history, decreased soft tissue vitality, history of radiotherapy or going to receive radiotherapy, active ulcer, etc;
3. With severe medical diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, autoimmune diseases, etc.) were complicated;
4. Those who are receiving anticoagulant therapy and cannot suspend treatment;
5. Those who are with abnormal blood routine test, abnormal coagulation function, abnormal cardiac function, abnormal liver function or renal function evaluated by researchers according to the laboratory examination and other clinical signs and symptoms,
6. Those who can't tolerate the operation risk according to the surgeon's evaluation;
7. Pregnant and lactating women;
8. Those who have mental illness, have no insight, can not express and cooperate with each other;
9. Participant in other clinical trials within 30 days before the screen visit of this trial;
10. Those who have not signed the informed consent.
6 Years
70 Years
ALL
No
Sponsors
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Huaxi Hospital
OTHER
Ruijin Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Qing-FengLi Li,MD
Director, Professor
Central Contacts
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Other Identifiers
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SH9H-2020-T185-1
Identifier Type: -
Identifier Source: org_study_id