Status:
ACTIVE_NOT_RECRUITING
Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Breast
Mammaplasty
Eligibility:
FEMALE
18-60 years
Brief Summary
Since polyacrylamide hydrogel (PAAG) was used in cosmetic surgery in 1997, about 30 million women have received PAAG injection for breast augmentation. Although the use of PAAG has been prohibited in ...
Detailed Description
The primary purposes of this study are to: 1. Compare the safety and effectiveness of IBR vs DBR after PAAG removal; 2. Compare the safety and effectiveness of breast implants with silicone gel prost...
Eligibility Criteria
Inclusion
- history of PAAG breast injection;
- appeal to remove the gel;
- availability of complete medical records;
- accepting the potential complications of the operation and breast deformity after gel removal.
- agreeing with medical history data collection, clinical follow-up investigation, and independent Complete the questionnaire.
Exclusion
- Patients who had other breast diseases;
- Patients who failed to follow the standard diagnosis, treatment and follow-up;
- Lost to follow-up due to various reasons or incomplete medical records;
- Patients with cognitive disorders such as mental illness, understanding, memory, or orientation, and other serious diseases.
Key Trial Info
Start Date :
October 18 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04715802
Start Date
October 18 2006
End Date
December 31 2025
Last Update
May 14 2025
Active Locations (1)
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1
Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003