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Real-world study on the effectiveness and safety evaluation of breast augmentation with silicone implant in China

Real-world study on the effectiveness and safety evaluation of breast augmentation with silicone implant in China

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034574
Enrollment
Unknown
Registered
2020-07-10
Start date
2020-07-07
Completion date
Unknown
Last updated
2022-09-20

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

Conditions

Mammary dyplasia

Interventions

Subpectoral plane group:Subpectoral plane
Subglandular plane group:Subpectoral plane
Subfascial plane group:Subfascial plane

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Subjects with primary mammary dysplasia, breast atrophy after lactation with or without mild ptosis who required prosthetic augmentation mammoplasty in the Plastic Surgery Department of The First Affiliated Hospital, College of Medicine, Zhejiang University; 2. Aged 18-60, female; 3. Patients who can cooperate with breast care and massage after operation; 4. All subjects should sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with or having other breast diseases in the past; 2. Those who have a history of breast plastic surgery such as breast augmentation with autologous fat or removal of prosthesis; 3. Patients who have undergone any previous breast surgery; 4. Patients with severe heart, lung, liver and kidney dysfunction indicated by medical history; 5. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Capsular contracture;Breast morphology;Breast-Q test;

Secondary

MeasureTime frame
hematoma;seroma;infection;reoperation;nipple numbness;muscle movement;implant visualization;implant malplacement;implant rupture;asymmetry;breast nodules;BIA-ALCL;

Countries

China

Contacts

Public ContactXu Jinghong

The First Affiliated Hospital, College of Medicine, Zhejiang University

1304017@zju.edu.cn+86 13732229034

Outcome results

None listed

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