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Study on the treatment of expansion complications through micro-fat and nanofat

Prospective randomized controlled trials on the treatment of expansion complications in the skin mechanical stretch through micro-fat and nanofat

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009854
Enrollment
Unknown
Registered
1990-01-01
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft tissue defect

Interventions

nanofat:nanofat grafting
micro-fat:micro-fat grafting

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong UNiversity School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 14-65 years old men and women; 2. Subcutaneous fat disappearance and thinner dermis appeared during the expansion detected by B-type ultrosound 3. Telangiectasia or stretch marks as early expansion complications; or pressure reducing difference is less than 5mmHg compared with the previous injection; 4. Sign informed consent to participate in this study and be able to cooperate with the completion of follow-up.

Exclusion criteria

Exclusion criteria: 1. Potential expansion risks exist in expansion areas, such as infection and, visible vascular embolism and expansion of the skin blood circulation disorders; soft tissue expansion activity decreased (such as the history of radiation or radiotherapy), expansion rupture or ulcer etc.; 2. Expander placed under the muscle or hair area; 3. The patients had abnormal cardiac function, abnormal liver function or abnormal renal function according to the laboratory examination and other clinical signs and symptoms; 4. Drug, stem cells, fat transplant or other intervention therapy was used or performed in 6 months; 5. Severe internal medicine diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerular nephritis, blood system diseases, autoimmune diseases, malignant tumors, etc.); 6. Under anticoagulant therapy or long-term use of blood circulation and anti drug discontinuation of health products in January; 7. With long history of smoking and 3 months had smokers; 8. Pregnant women and lactating women; 9. With mental disease, no insight, can not be exact expression and cooperation; 10. Participated in other clinical trials within 60 days before the screening visit.

Design outcomes

Primary

MeasureTime frame
Expansion Index;

Secondary

MeasureTime frame
Expanded skin area;Thickness of expanded skin;Texture of expanded skin;Contracture rate of flap;

Countries

China

Contacts

Public ContactYun Xie

Shanghai Ninth People's Hospital, Shanghai Jiaotong UNiversity School of Medicine

amiyayun@qq.com+86 13817633803

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026