Capsular Contracture Associated With Breast Implant, Capsular Contracture Grade III, Capsular Contracture Grade IV
Conditions
Brief summary
Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Subjects will be randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care (no ADM or matrix placement). This study is designed using an adaptive approach. The number of the treated breasts will range between 250 and 530.
Detailed description
Capsular contracture is the number one complication leading to revision surgery after breast augmentation(2-4) which has been commonly cited as impacting 10 to 20% of all breast augmentation patients.(5-10) A prospective, randomized controlled study of patients presenting with Baker grade III or IV capsular contracture will be undertaken to investigate the ability of P4HB (specifically GalaFLEX LITE™ Scaffold) to reduce the recurrence of clinically significant CC and/or malposition requiring surgical correction. The primary endpoint is a composite of capsular contracture recurrence and/or breast implant malposition recommended for surgery OR breast infections requiring oral or IV antibiotic treatment within 90 days of surgery and/or peri-implant fluid collection needing a drainage procedure within 10-90 days of surgery.
Interventions
DEVICEGalaFLEX LITE™ Scaffold
Bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB) and knitted into a surgical scaffold used to reinforce soft tissue
OTHERStandard surgery
Surgery performed without the use of a scaffold
Sponsors
C. R. Bard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will not be made aware of whether they receive standard-of-care surgery or surgery with the study device. They will be made aware at the end of the study.
Intervention model description
Multi-center, prospective, randomized
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Genetically female ≥22 and ≤70 years of age; 2. Breast augmentation subject with capsular contracture (Baker grade III or IV); 3. Desires a new silicone implant with no more than a ± 150cc volume change in implant size; 4. Planned revision approach via inframammary fold (IMF) incision; 5. Willing and able to comply with the study procedures including the 2-year follow-up visit; 6. Can complete all required study visits as scheduled (i.e., physically attend); 7. Has reviewed and completed an FDA required Breast Implant Patient Decision Checklist (e.g., implant-specific provided by the manufacturer); 8. Has compatible smart technology that can be used for downloading/using the electronic patient diary; and, 9. Provision of signed and dated informed consent form.
Exclusion criteria
1. BMI \<18 or \>35 2. Existing and/or replacement implant size \> 800 cc 3. Has an extra-capsular silicone breast implant rupture where silicone gel has leaked outside of the capsule) in breast(s) intended for treatment 4. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment 5. Abnormal breast findings on imaging within 1-year prior to randomization that have not been determined to be benign 6. Subject reported current, or prior history of, Systemic Symptoms Associated with Breast Implants (SSBI - formerly referred to as BII (Breast Implant Illness)) 7. Infection present in the study breast(s) (day of index procedure (surgery) exclusions) 8. Current or recent breastfeeding (within 3-months of enrollment) or history of mastitis within the 6-months prior to enrollment 9. Prior or current diagnosis of breast cancer 10. Has a mass that was palpated and has not been determined benign via acceptable imaging (MRI) or biopsy results 11. Has undergone prior chest radiation treatment 12. Has received chemotherapy within the last 12 months 13. Current or recent (within 1-year of enrollment) alcohol/substance abuse 14. Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes, vaping, patches, gum, etc.) 15. History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIAALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC) 16. Planned use of any other matrix (synthetic, biosynthetic, or biological) in the study breast(s) other than the GalaFLEX LITE™ Scaffold used to fully wrap the implant 17. Planned (within the 2-year follow-up time period) use of medical (e.g. montelukast/Singulair; zafirlukast/Accolate), physical (e.g. massage), or device assisted (e.g. mechanical/thermal ultrasound) tools to manage the breast capsule(s) 18. Any medical condition that, in the opinion of the investigator, may be associated with unduly high risk of intra- or post-operative complications (e.g., insulin dependent diabetes, autoimmune disease, connective tissue disorder, chronic lung or severe cardiovascular disease) 19. Concurrent or planned use (within the 2-year follow-up time period) of autologous fat transfer in the study breast(s) 20. Planned (within the 2-year follow-up time period) elective cosmetic surgery on the study breast(s) (e.g., staged mastopexy; revision for implant size change) 21. Currently enrolled or has plans to enroll in another interventional clinical study that would interfere with this study 22. Is pregnant or plans to become pregnant during the study period 23. Known allergy to tetracycline hydrochloride and/or kanamycin sulfate 24. Any condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes 25. Subject will not remain under the care of the investigator for all breast related plastic surgery procedures while enrolled in the study 26. Actively using immunosuppressants such as oral steroids or biological therapies (inhalers or topical steroids are permitted) 27. Confirmed diagnosis of the following rheumatic diseases or syndromes: systemic lupus erythematosus, Sjorgren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome 28. Has, in the investigator's opinion, a mental illness or disability that would preclude their participation in the study 29. Subject has an implant that was never commercially available in the United States 30. Has been implanted with any silicone implant other than breast implants 31. Is taking any drugs that would interfere with blood clotting or might result in elevated risk of significant postoperative complications (e.g., anticoagulants or antiplatelet medications such as Xarelto, Aspirin, or Eliquis. NSAIDs such as Celebrex, Ibuprofen, Meloxicam are not exclusionary). 32. Works for Sponsor or any of their subsidiaries, the study surgeon, or is helping to conduct the study or are directly related to anyone that works for BD or any of their subsidiaries or the study surgeons 33. Subjects planning to undergo significant weight loss utilizing surgical intervention or prescribed medication(s) (e.g., gastric bypass; gastric sleeve; GLP1 agonists). Subjects with stable weight after previous surgery or current GLP-1 agonists use are not excluded. Day of Index Procedure (Surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket | 24-months after index surgery | Composite of Recurrent Capsular Contracture Baker grade III/IV and/or breast implant malposition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient quality of life and satisfaction (12-month) | 12-months after index surgery | Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest |
| Patient quality of life and satisfaction | 24-months after index surgery | Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest |
| Safety of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket, reduction of capsular contracture recurrence, and/or malposition | 90 days | The occurrence of: * Breast fluid collection requiring a drainage procedure at any time, or after drain removal if one is used, within 90 days of surgery * Breast infection requiring oral (PO) or intravenous (IV) antibiotics related to the contracture revision surgery within 90 days of surgery |
Countries
United States
Contacts
CONTACTNiccole Diaz
CONTACTJenna Baccari
Outcome results
None listed