- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04715802
Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
January 31, 2021 updated by: First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital, College of Medicine, Zhejiang University
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
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
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
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310003
- Department of Plastic and Reconstructive Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University
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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
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
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:
- 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 Criteria:
- 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.
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 |
Intervention / Treatment |
---|---|
PAAG removal + Immediate implant reconstruction
Patients who had a one-stage operation comprising gel removal and immediate breast reconstruction.
|
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:
|
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.
|
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:
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PAAG removal + No breast reconstruction
Patients who only underwent surgical PAAG removal without breast reconstruction.
|
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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.
|
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:
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PAAG removal + breast reconstruction with implants
Patients who underwent surgical PAAG removal with immediate or delayed implant breast reconstruction.
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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).
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What is the study measuring?
Primary Outcome Measures
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.
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until 10 years post operation
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The probability of reoperations
Time Frame: until 10 years post operation
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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.
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until 10 years post operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-reported quality of life, QOL
Time Frame: until 1 year post operation
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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.
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until 1 year post operation
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Aesthetic evaluation
Time Frame: until 1 year post operation
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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.
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until 1 year post operation
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change in patient satisfaction
Time Frame: until 1 year post operation
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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".
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until 1 year post operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 18, 2006
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
January 10, 2021
First Submitted That Met QC Criteria
January 18, 2021
First Posted (Actual)
January 20, 2021
Study Record Updates
Last Update Posted (Actual)
February 3, 2021
Last Update Submitted That Met QC Criteria
January 31, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID 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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