BreastNCT04715802
Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
An observational study of Breast and Mammaplasty, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast, Mammaplasty, Breast Reconstruction
- What is being tested?
- Immediate breast reconstruction with implant, delayed breast reconstruction with implant and delayed breast reconstruction with autologous fat transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2006to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: 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.
Read the detailed description
The primary purposes of this study are to:
- Compare the safety and effectiveness of IBR vs DBR after PAAG removal;
- Compare the safety and effectiveness of breast implants with silicone gel prosthesis vs autologous fat transplantation after PAAG removal;
- Evaluate the clinical characteristics associated with and rates of complications based on reconstruction timing and type.
The secondary purposes of this study are to：
- Explore and summarize the characteristics of long-term complications of PAAG injection for breast augmentation;
- 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.
- Further refine the algorithm for breast reconstruction in patients with PAAG injections.
- Conditions
- Breast, Mammaplasty, Breast Reconstruction
- Being tested
- Immediate breast reconstruction with implant, delayed breast reconstruction with implant, delayed breast reconstruction with autologous fat transplantation
- Keywords
- polyacrylamide hydrogel (PAAG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate breast reconstruction with implantProcedure or surgery
Also called Breast-Q questionnaire
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 implantProcedure or surgery
Also called Breast-Q questionnaire
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 transplantationProcedure or surgery
Also called Breast-Q questionnaireBreast-Q questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| PAAG removal + Immediate implant reconstruction | Patients who had a one-stage operation comprising gel removal and immediate breast reconstruction. Receives: Procedure: Immediate breast reconstruction with implant | |
| 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. Receives: Procedure: delayed breast reconstruction with implant | |
| 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. Receives: Procedure: delayed breast reconstruction with autologous fat transplantation | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: until 10 years post operation
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.
Measured: until 10 years post operation
Secondary outcomes (3)
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.
Measured: until 1 year post operation
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.
Measured: until 1 year post operation
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".
Measured: until 1 year post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start18 Oct 2006
- Primary completion31 Dec 2022
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715802
- Sponsor's protocol ID
- IIT20200748A
- Status last verified
- May 2025
- First submitted
- 10 Jan 2021
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Options of Breast Reconstruction Timing and Method After Removing of Polyacrylamide Hydrogel: a Propensity Score-matched Study
- ClinicalTrials.gov ID
- NCT04715802
- Acronym / sponsor ID
- IIT20200748A
- Conditions
- Breast, Mammaplasty, Breast Reconstruction
- Keywords
- polyacrylamide hydrogel (PAAG)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 18 Oct 2006 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary purposes of this study are to:
- Compare the safety and effectiveness of IBR vs DBR after PAAG removal;
- Compare the safety and effectiveness of breast implants with silicone gel prosthesis vs autologous fat transplantation after PAAG removal;
- Evaluate the clinical characteristics associated with and rates of complications based on reconstruction timing and type.
The secondary purposes of this study are to：
- Explore and summarize the characteristics of long-term complications of PAAG injection for breast augmentation;
- 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.
- Further refine the algorithm for breast reconstruction in patients with PAAG injections.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PAAG removal + Immediate implant reconstruction | – | Procedure: Immediate breast reconstruction with implantPatients who had a one-stage operation comprising gel removal and immediate breast reconstruction. |
| PAAG removal + Delayed implant reconstruction | – | Procedure: delayed breast reconstruction with implantPatients 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. |
| PAAG removal + No breast reconstruction | – | –Patients who only underwent surgical PAAG removal without breast reconstruction. |
| PAAG removal + Delayed autologous fat grafting reconstruction | – | Procedure: delayed breast reconstruction with autologous fat transplantationPatients 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. |
| 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate breast reconstruction with implantAlso: Breast-Q questionnaireBecause 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 or surgery | PAAG removal + Immediate implant reconstruction |
| delayed breast reconstruction with implantAlso: Breast-Q questionnaireThe 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 or surgery | PAAG removal + Delayed implant reconstruction |
| delayed breast reconstruction with autologous fat transplantationAlso: Breast-Q questionnaireBreast-Q questionnaireBecause 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. | Procedure or surgery | PAAG removal + Delayed autologous fat grafting reconstruction |
Primary outcome
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.
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.
3 secondary outcomes
Patient-reported quality of life, QOL
Time frame: until 1 year post operation
Aesthetic evaluation
Time frame: until 1 year post operation
change in patient satisfaction
Time frame: until 1 year post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast and Mammaplasty, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the occurrence of a postoperative complication (time frame: until 10 years post operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.