Clinical Research of Soft Tissue Defect Reconstruction after Resection of Benign Tumors with Stromal Vascular Fraction and Autologous Fat Grafting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009948

Enrollment

Registered

2024-11-26

Start date

2024-11-11

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None listed

Interventions

Procedure/Surgery : Experimental group: Stromal vascular fraction (SVF) and autologous fat, 1 ml per 1 cm3 (SVF mixed with autologous fat at 1/4 volume per 1 ml), single dose, local injection Control

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A person who has undergone excision of a benign tumor in a commonly exposed body part, such as the skull, face, or limbs, and has a soft tissue defect measuring 2-12 cm in diameter and requires reconstructive treatment due to functional or abstract problems.

Exclusion criteria

Exclusion criteria: A. Those with uncorrected blood coagulation disorder (Platelet2) B. Those receiving long-term (3 months or more) immunosuppressants, corticosteroids, etc. C. Those who are pregnant or lactating, or women of childbearing age who do not agree to maintain contraception during the study period D. Those diagnosed with malignant tumors and undergoing or planning to undergo chemotherapy, radiotherapy, etc. E. Those who have soft tissue defects but do not have functional problems and are not recognized as having an abdominal disability and are judged to require non-covered cosmetic surgery F. Those who are judged to be unable to collect sufficient fat tissue (minimum 50 cc or more) G. Those who participated in another medical device intervention clinical trial within 6 months prior to participating in this study or participated in a pharmaceutical intervention clinical trial within 30 days H. Those who are judged by other researchers to be inappropriate for participation in the clinical trial

Design outcomes

Primary

Measure	Time frame
Soft tissue defect recovery rate at 24 weeks postoperatively compared to preoperatively (%)	—

Secondary

Measure	Time frame
Changes in satisfaction assessed by researchers and subjects 24 weeks after surgery compared to before surgery	—

Countries

Korea, Republic of

Contacts

Public ContactJieun Jung

Seoul National University Hospital

jj9420@naver.com+82-2-3095-0426

Outcome results