Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466765
Status:
COMPLETED
Last Update Posted:
2015-05-05
First Post:
2007-04-25
Brief Title:
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
Sponsor:
Brava
Organization:
Brava
Study Overview
Official Title:
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro grafting breast augmentation and reconstruction procedures
Detailed Description:
Procedure
Urine pregnancy test will be performed before each designated procedure in the study Patients will be questioned about underlying renal disease and excluded if existent
Pre-operativebaseline digital or 35mm photos will be obtained utilizing the standard criteria as performed routinely by plastic and reconstructive surgeons before any surgical procedure Oblique frontal and sagittal views will be stored in protected files
Optional Patients will have a preoperative breast MRI with the contrasting agent Gadolinium utilizing a 15 Tesla MRI machine and breast coils unless status post breast cancer where no pre-operative MRI is needed All readings will be performed by board certified radiologists
Brava domes will be worn bilaterally 3-4 weeks before surgery for 10-12 hours per day 7 days a week with 24 hour wear for the final 72 hours 3 days before surgery Patients will be required to adhere to the dome cleaning process specified by the manufacturer This is prudent for hygienic reasons and to reduce skin irritation and infections The domes are for single patient use only Pressure will range from 15 mmHg to 105mmHg and will be achieved and regulated by either SmartBox bulb syringe andor Brava Turbo devices This will open up the tissue planes and maximally expand the recipient breast in preparation for graft insertion
Institutional Review Board approval will be obtained and all patients will be properly advised of their rights via signed Informed Consents
All patients will be assessed by board certified plastic and reconstructive surgeons for autologous fat harvesting sites Preoperative sedation with IV sedation andor oral sedation is recommended Preoperative antibiotics such as Keflex or similar drug will be administered before surgery Sterile drape and prep of the fat harvesting sites will be carried out
Tumescent anesthetic solution will be prepared by diluting 50ccs of 1 lidocaine with 1100000 units of epinephrine with 1000ccs of Ringers Lactate solution and will be instilled with a 14-gauge infusion infiltration cannula into the areas of fat harvesting
Gentle low vacuum pressure manual liposuction will be performed to avoid damaging the fat cells Liposuction will be performed in a standard fashion using 12G 12 side holes harvesting cannulas and connected to syringes that maintain a controlled constant low vacuum pressure of 300 mmHg preferably using the K-VAC Vacuum Assisted Device syringe The aspirate will be purged from the syringes into collection bags using atraumatic nonclogging valves preferably the AT-Valve or 3 way stopcocks Once filled the bags will be spun at low speed 1000 rpm to separate fat from serum and free of oil if any The infranatant serum will be drained and the cellular fat supernatant will be concentrated in the bags and directly re-injected into the breasts Depending upon the volume correction required and the recipient space available 100 to 500 ml of gently centrifuged non-packed fat will be injected per breast
The recipient breast will be marked carefully prior to infiltration of anesthetics to determine the preferred graft distribution pattern and to select 9-18 graft insertion sites circumareolar inframammary axillary and at the circumference of the breast The skin will be infiltrated at the graft insertion sites with Naropin 2 ropivacine
After the recipient site is anesthetized puncture sites will be made with a 14-gauge needle A 14-gauge blunt tip cannula or similar cannula connected to a 3 ml syringe is used to gently inject small droplets distally first and then subsequently proximally as the cannula is withdrawn Repeated passes at multiple levels in a radial fashion are performed through each of the puncture sites such that the grafts droplets are laid down in a criss-crossing pattern and at multiple planes Avoid the glandular tissue by remaining in the subcutaneous plane and if more volume is needed and is available proceed to fill the subglandular intramuscular and submuscular planes Incision sites are covered with sterile band aids applied to skin Gentle conforming dressings will be applied to breast
Elastic garments will be placed on harvest site Postoperative instructions are handed to each patient Patient will begin wearing the Brava System with the SmartBox device only 18 hours post-operative as a stabilization device For the first three 3 days the system is worn 24 hours a day or as to the maximum tolerated If the patient notes pain the system may be removed and replaced a few hours later The System is then worn 10 to 12 hours a day for one additional week 7 days Then the patient may choose to proceed with a prolonged intermittent wear of 10 hours per day for 10 - 14 weeks
Follow-up will include A call from the surgical team within 24 hours after surgery An office follow up visit within 48-72 hours of surgery and follow-up appointment in 6 months More office follow up visits in the interim are recommended but not mandatory
A one-year post grafting mammogram will be recommended to all women over the age of 40
Urine pregnancy test will be performed before each designated procedure in the study Patients will be questioned about underlying renal disease and excluded if existent
Pre-operativebaseline digital or 35mm photos will be obtained utilizing the standard criteria as performed routinely by plastic and reconstructive surgeons before any surgical procedure Oblique frontal and sagittal views will be stored in protected files
Optional Patients will have a preoperative breast MRI with the contrasting agent Gadolinium utilizing a 15 Tesla MRI machine and breast coils unless status post breast cancer where no pre-operative MRI is needed All readings will be performed by board certified radiologists
Brava domes will be worn bilaterally 3-4 weeks before surgery for 10-12 hours per day 7 days a week with 24 hour wear for the final 72 hours 3 days before surgery Patients will be required to adhere to the dome cleaning process specified by the manufacturer This is prudent for hygienic reasons and to reduce skin irritation and infections The domes are for single patient use only Pressure will range from 15 mmHg to 105mmHg and will be achieved and regulated by either SmartBox bulb syringe andor Brava Turbo devices This will open up the tissue planes and maximally expand the recipient breast in preparation for graft insertion
Institutional Review Board approval will be obtained and all patients will be properly advised of their rights via signed Informed Consents
All patients will be assessed by board certified plastic and reconstructive surgeons for autologous fat harvesting sites Preoperative sedation with IV sedation andor oral sedation is recommended Preoperative antibiotics such as Keflex or similar drug will be administered before surgery Sterile drape and prep of the fat harvesting sites will be carried out
Tumescent anesthetic solution will be prepared by diluting 50ccs of 1 lidocaine with 1100000 units of epinephrine with 1000ccs of Ringers Lactate solution and will be instilled with a 14-gauge infusion infiltration cannula into the areas of fat harvesting
Gentle low vacuum pressure manual liposuction will be performed to avoid damaging the fat cells Liposuction will be performed in a standard fashion using 12G 12 side holes harvesting cannulas and connected to syringes that maintain a controlled constant low vacuum pressure of 300 mmHg preferably using the K-VAC Vacuum Assisted Device syringe The aspirate will be purged from the syringes into collection bags using atraumatic nonclogging valves preferably the AT-Valve or 3 way stopcocks Once filled the bags will be spun at low speed 1000 rpm to separate fat from serum and free of oil if any The infranatant serum will be drained and the cellular fat supernatant will be concentrated in the bags and directly re-injected into the breasts Depending upon the volume correction required and the recipient space available 100 to 500 ml of gently centrifuged non-packed fat will be injected per breast
The recipient breast will be marked carefully prior to infiltration of anesthetics to determine the preferred graft distribution pattern and to select 9-18 graft insertion sites circumareolar inframammary axillary and at the circumference of the breast The skin will be infiltrated at the graft insertion sites with Naropin 2 ropivacine
After the recipient site is anesthetized puncture sites will be made with a 14-gauge needle A 14-gauge blunt tip cannula or similar cannula connected to a 3 ml syringe is used to gently inject small droplets distally first and then subsequently proximally as the cannula is withdrawn Repeated passes at multiple levels in a radial fashion are performed through each of the puncture sites such that the grafts droplets are laid down in a criss-crossing pattern and at multiple planes Avoid the glandular tissue by remaining in the subcutaneous plane and if more volume is needed and is available proceed to fill the subglandular intramuscular and submuscular planes Incision sites are covered with sterile band aids applied to skin Gentle conforming dressings will be applied to breast
Elastic garments will be placed on harvest site Postoperative instructions are handed to each patient Patient will begin wearing the Brava System with the SmartBox device only 18 hours post-operative as a stabilization device For the first three 3 days the system is worn 24 hours a day or as to the maximum tolerated If the patient notes pain the system may be removed and replaced a few hours later The System is then worn 10 to 12 hours a day for one additional week 7 days Then the patient may choose to proceed with a prolonged intermittent wear of 10 hours per day for 10 - 14 weeks
Follow-up will include A call from the surgical team within 24 hours after surgery An office follow up visit within 48-72 hours of surgery and follow-up appointment in 6 months More office follow up visits in the interim are recommended but not mandatory
A one-year post grafting mammogram will be recommended to all women over the age of 40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None