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

May 12, 2025 updated by: First Affiliated Hospital of Zhejiang University

Options of Breast Reconstruction Timing and Method After Removing of Polyacrylamide Hydrogel: a Propensity Score-matched Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who were admitted to the Plastic Surgery Department of the First Affiliated Hospital of Zhejiang University School of Medicine with complications after receiving PAAG injection for breast augmentation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PAAG removal + Immediate implant reconstruction
Patients who had a one-stage operation comprising gel removal and immediate breast reconstruction.
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.
Other Names:
  • Breast-Q questionnaire
PAAG removal + Delayed implant reconstruction
Patients who had a two-stage operation comprising gel removal and delayed breast reconstruction at least 3 months later. The first 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 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.
Other Names:
  • Breast-Q questionnaire
PAAG removal + No breast reconstruction
Patients who only underwent surgical PAAG removal without breast reconstruction.
PAAG removal + Delayed autologous fat grafting reconstruction
Patients who underwent a two-stage operation comprising surgical PAAG removal and autologous fat injection at least 3months later. Usually, the amount of transplanted fat was 150-200mL/side. A multilayer and multi-tunnel injection method was commonly used.
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.
Other Names:
  • Breast-Q questionnaireBreast-Q questionnaire
PAAG removal + breast reconstruction with implants
Patients who underwent surgical PAAG removal with immediate or delayed implant breast reconstruction.
Primary breast augmentation with implants
Patients who had undergone conventional breast augmentation(BA) with implants during the study period who matched the study cohort by age(±5 years).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the occurrence of a postoperative complication
Time Frame: until 10 years post operation
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
The probability of reoperations
Time Frame: until 10 years post operation
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-reported quality of life, QOL
Time Frame: until 1 year post operation
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
Aesthetic evaluation
Time Frame: until 1 year post operation
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
change in patient satisfaction
Time Frame: until 1 year post operation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT20200748A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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