Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation
Purpose
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.
Conditions
- Capsular Contracture Associated With Breast Implant
- Capsular Contracture Grade III
- Capsular Contracture Grade IV
Eligibility
- Eligible Ages
- Between 22 Years and 66 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Genetically female ≥22 and ≤66 years of age; 2. Breast augmentation subject with capsular contracture (Baker grade III or IV); 3. Desired a new implant with no more than a 25% increase in implant size (not to exceed a volume increase greater than 150cc compared to the existing implant); 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. Lives within 3 hours driving distance from the investigator site; and, 7. Provision of signed and dated informed consent form.
Exclusion Criteria
- BMI <18 or >35 2. Existing and/or replacement implant size > 800 cc 3. Had ≥2 capsular contracture revisions on the breast(s) intended for treatment 4. Has an extra-capsular rupture (breast implant silicone gel or saline has leaked outside of the capsule) in breast(s) intended for treatment 5. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment. 6. Abnormal findings on diagnostic imaging within 1-year of study enrollment (mammogram for patients ≥35 years old; MRI for patients <35 years old or breast ultrasound if MRI is contraindicated) 7. Has symptoms consistent with Breast Implant Illness (BII)Systemic Symptoms Associated with Breast Implants (SSBI) 8. Infection present in the breast (day of surgery exclusions are noted in Section 5.3) 9. Current or recent breast feeding (within 3-months or enrollment) or history of mastitis within the 6-months prior to enrollment 10. Prior or current diagnosis of breast cancer 11. Has a mass that was palpated and has not been determined benign via acceptable imaging (MRI) or biopsy results 12. Has undergone prior chest radiation treatment 13. Has received chemotherapy within the last 12 months 14. Current or recent (within 1-year of enrollment) alcohol/substance abuse 15. Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes, vaping, patches, gum, etc.) 16. History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC) 17. Planned use of another type of matrix (such as ADM) in addition to GalaFLEX LITE™ 18. Current or planned use of medical (e.g. Singulair), physical (e.g. massage), or device-assisted (e.g. mechanical/thermal ultrasound) tools to manage the breast capsule(s) 19. 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) 20. Concurrent or planned (within the 2-year follow-up time period) elective cosmetic breast operation to the treated breast (e.g., autologous fat transfer, mastopexy, or implant size changes) 21. Currently enrolled or has plans to enroll in another clinical study that would interfere with this study, unless it is a retrospective or observational study 22. Is pregnant or plans to become pregnant during the study period 23. Known allergy to tetracycline hydrochloride and 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 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 (had their breast augmentation in another country) 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 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. -
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Multi-center, prospective, randomized
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental GalaFlex Light Scaffold |
Surgery performed with GalaFlex Lite Scaffold. |
|
|
Active Comparator Standard Surgery |
Surgery performed using standard surgical procedures with no scaffold. |
|
Recruiting Locations
The Practice Plastic Surgery
Beverly Hills 5328041, California 5332921 90210
Beverly Hills 5328041, California 5332921 90210
Donald S Mowlds, MD A Professional Corporation
Newport Beach 5376890, California 5332921 92660
Newport Beach 5376890, California 5332921 92660
Newport Plastic and Reconstructive Surgery Associates
Newport Beach 5376890, California 5332921 92660
Newport Beach 5376890, California 5332921 92660
Careaga Plastic Surgery
Miami 4164138, Florida 4155751 33134
Miami 4164138, Florida 4155751 33134
Billington Plastic Surgery
St. Petersburg 4171563, Florida 4155751 33710
St. Petersburg 4171563, Florida 4155751 33710
VIVIFY Plastic Surgery
Tampa 4174757, Florida 4155751 33606
Tampa 4174757, Florida 4155751 33606
The Graivier Center
Alpharetta 4179574, Georgia 4197000 30005
Alpharetta 4179574, Georgia 4197000 30005
Meridian Plastic Surgery Center
Indianapolis 4259418, Indiana 4921868 46290
Indianapolis 4259418, Indiana 4921868 46290
Reno Tahoe Plastic Surgery
Reno 5511077, Nevada 5509151 89511
Reno 5511077, Nevada 5509151 89511
Plastic Surgery Institute of New York
New York 5128581, New York 5128638 10036
New York 5128581, New York 5128638 10036
H/K/B Surgery
Huntersville 4472370, North Carolina 4482348 28078
Huntersville 4472370, North Carolina 4482348 28078
Essential Medical Research
Tulsa 4553433, Oklahoma 4544379 74137
Tulsa 4553433, Oklahoma 4544379 74137
Pittsburgh Center for Plastic Surgery
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
The Plastic Surgery Center of Nashville With HKB
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
Southwest Plastic Surgery
El Paso 5520993, Texas 4736286 79936
El Paso 5520993, Texas 4736286 79936
Aesthetic Center for Plastic Surgery
Houston 4699066, Texas 4736286 77024
Houston 4699066, Texas 4736286 77024
The Plastics Clinic
Draper 5774001, Utah 5549030 84020
Draper 5774001, Utah 5549030 84020
Allen Gabriel MD
Vancouver 5814616, Washington 5815135 98660
Vancouver 5814616, Washington 5815135 98660
More Details
- NCT ID
- NCT05945329
- Status
- Recruiting
- Sponsor
- C. R. Bard
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.