Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel

Active, not recruitingOBSERVATIONAL
Enrollment

240

Participants

Timeline

Start Date

October 18, 2006

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2025

Conditions
BreastMammaplastyBreast Reconstruction
Interventions
PROCEDURE

Immediate breast reconstruction with implant

Because most fillers are under the mammary gland, it is better to place the prosthesis into the opening under the pectoralis major muscle, which avoids contact between the prosthesis and the residual hydrogel to reduce the chance of infection. If postoperative complications disappear and imaging shows no filler remnants after more than 3-month follow-up, secondary breast augmentation can be planned. For placement of the prosthesis, the plane under the pectoralis major is preferred, which avoids prosthesis contact with the residual hydrogel to thus reduce the chance of infection.

PROCEDURE

delayed breast reconstruction with implant

The first stage included maximal gel removal and purulent tissue debridement, if necessary. Thereafter, patients were invited for a clinical follow-up and discussion about DBR 3 months later. The latter was offered as a second stage in those opting for it.

PROCEDURE

delayed breast reconstruction with autologous fat transplantation

Because fat injection after PAAG removal has a high infection risk, it is recommended to be conducted after 3-6 months of follow-up. The advantage of autologous fat transplantation is its ability to repair a variety of breast shape deformities caused by PAAG removal. Fat injections may need to be repeated several times. The interval between injections should be at least 3 months. Usually, the amount of transplanted fat is 150-200 mL/side. A multilayer and multi-tunnel injection method is commonly used.

Trial Locations (1)

310003

Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou

All Listed Sponsors
lead

First Affiliated Hospital of Zhejiang University

OTHER