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

Breast Reconstruction Clinical Trial

Official title:

The First Affiliated Hospital, College of Medicine, Zhejiang University

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04715802
• Other study ID #: IIT20200748A
• Status: Active, not recruiting
• Start date: October 18, 2006
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2020
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 most countries due to its myriad complications, a large number of symptomatic patients and asymptomatic patients have continued to seek medical advice. The strategy of repairing secondary breast deformities after PAAG removal has increasingly become a concern for both doctors and patients, but there is no standardized algorithm yet. The purpose of the present study was to perform a retrospective study to compare the safety and effectiveness of different reconstruction timing and method after removing the gel.

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 prosthesis vs autologous fat transplantation after PAAG removal; 3. Evaluate the clinical characteristics associated with and rates of complications based on reconstruction timing and type. The secondary purposes of this study are to： 1. Explore and summarize the characteristics of long-term complications of PAAG injection for breast augmentation; 2. Compare the rate of postoperative complications and reoperations between the patients who had breast reconstruction with implants and patients who had primary breast augmentation with implants. 3. Further refine the algorithm for breast reconstruction in patients with PAAG injections.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. history of PAAG breast injection;

2. appeal to remove the gel;

3. availability of complete medical records;

4. accepting the potential complications of the operation and breast deformity after gel removal.

5. agreeing with medical history data collection, clinical follow-up investigation, and independent Complete the questionnaire.

Exclusion Criteria:

1. Patients who had other breast diseases;

2. Patients who failed to follow the standard diagnosis, treatment and follow-up;

3. Lost to follow-up due to various reasons or incomplete medical records;

4. Patients with cognitive disorders such as mental illness, understanding, memory, or orientation, and other serious diseases.

Related Conditions & MeSH terms

• Breast
• Breast Reconstruction
• Mammaplasty

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the occurrence of a postoperative complication	Complications are defined as any adverse postoperative events directly related to gel removal or breast reconstruction surgery that require further treatment. According to the patient's main complaint, physical examination, chest radiography, breast ultrasound, breast mammography or MRI, pathological biopsy and other methods to evaluate the complications. According to the degree of complications, they were further divided into: (1) Mild complications: conservative treatment without surgical treatment. (2) Severe complications: the incidence of complications requiring reoperations or implant removal/replacement operations.	until 10 years post operation
Primary	The probability of reoperations	Reoperation was defined as a surgical event performed after PAAG removal alone or stage I and II reconstruction. An anticipated operation of delayed breast implantation in patients with two-stage surgery was not classified as reoperation.	until 10 years post operation
Secondary	Patient-reported quality of life, QOL	Patient-reported quality of life using Breast-Q score to evaluate changes in breast appearance, mental health, physical health and sexual health satisfaction before and after surgery.	until 1 year post operation
Secondary	Aesthetic evaluation	It was evaluated by the Aesthetic Items Scale, which was a standardized tool for evaluating the aesthetic effect of breast reconstruction surgery, which was first proposed by Visser and Brinkman. The specific method was as follows: 3 experienced plastic surgeons evaluate 5 standardized photos (front, oblique, and side) of the patient before and after surgery. All photos were organized into slides and displayed randomly, with other information hidden (Such as preoperative or postoperative state, reconstruction method used, complications or whether to perform a second operation, etc.). In order to minimize the deviation, blank slides were displayed between the photos, and the random order of the photos of each observer was different. Each doctor used a five-point Likert scale to score breast volume, shape, symmetry, scars, and nipple areola. In addition, each doctor gave an overall satisfaction score between 0-10 points based on pre- and post-operative photos.	until 1 year post operation
Secondary	change in patient satisfaction	Patient satisfaction consisted of four structured questions that assessed satisfaction with the size, shape, symmetry, and sensitivity of the breast. Patients were asked to rate their final result as "good", "satisfactory", "poor" or "bad".	until 1 year post operation