The implantation of silicone-based breast implants is a commonly used procedure for breast augmentation and reconstruction of the breast. Despite extensive clinical experience, there is continued concern about the safety of these devices. Potential…
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Dissatisfaction with appearance of the breast
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
No statistical hypothesis testing will be done for the primary endpoint,
incidence of uSADEs. The objective of the study is not met if at least one
uSADE will be reported during the study.
Subject reported outcome: Questionnaire
Investigator reported outcome: Questionnaire
Secondary outcome
No statistical hypothesis testing will be done for the primary endpoint,
incidence of uSADEs. The objective of the study is not met if at least one
uSADE will be reported during the study.
Subject reported outcome: Questionnaire
Investigator reported outcome: Questionnaire
Background summary
A novel coating of silk proteins was developed to improve the tolerability of
breast implants and the special biocompatible properties of the silk proteins
should help to achieve this. A capsule is formed around every implant as a
natural reaction of the body to the implant. This so called capsular fibrosis,
which can be very painful. The aim of the study is to demonstrate the safety
and performance of silk-coated SILKLine breast implants.
For this purpose, 100 healthy subjects are included in the clinical trial.
After obtaining informed consent from the participant and after the screening
visit has been performed, the SILKLine implants will be implanted. In the
following observation period, the subjects are checked in 5 study visits
(including physical examinations, photo documentation, concomitant medication
and adverse events).
The investigational device, SILKline silicone breast implant, is based on a
standard textured and CE-certified silicone implant, consisting of polydimethyl
siloxane (PDMS, silicone) components as shell material (filled with a PDMS
gel), which is additionally amended by a thin layer of eADF4(C16) silk coating
(silk protein supplied by AMSilk GmbH, Germany).
Study objective
The implantation of silicone-based breast implants is a commonly used procedure
for breast augmentation and reconstruction of the breast.
Despite extensive clinical experience, there is continued concern about the
safety of these devices. Potential clinical complications include among others
capsular fibrosis also known as capsular contracture, hematoma, seroma or
infection. The investigational device addressed in this clinical investigation
plan (CIP) is based on a standard textured and CE-certified silicone implant.
It is additionally amended by a thin layer of eADF4(C16) silk coating on the
surface to physically veil the abiotic silicone surface during the first weeks
after implantation. It is expected that through this coating foreign body
reactions are significantly mitigated thereby improving the tolerability of the
device. The objective of this study is to evaluate the safety and performance
of the investigational device.
Study design
This is a prospective, single-arm, open-label, multicenter clinical safety
investigation with a total study duration of 12 months. Eligible subjects will
undergo baseline assessments (Visit 1, Day -14) and will receive SILKline
breast implants on Day 0 (Visit 2). Follow-up clinic visits will be performed
at Days 4, 30, 90, 180, and 360 (Visits 3, 4, 5, 6, and 7) to assess safety and
performance.
The study will include healthy female subjects. An interim analysis is planned
3 months after the last subject received surgery. The investigational device is
intended to stay in situ for the entire implant*s lifetime or until the subject
desires explantation for whatever reason.
Intervention
Yes: Surgery for breast augmentation
Study burden and risks
Silicone based breast implants are available since decades, have already been
used millenarily and are generally considered safe products. Nevertheless some
patients experience complications like for example the formation of so called
capsular fibrosis.The reasons for their formation are the subject of current
research, however it is believed that interactions between the material
implanted and the surrounding tissue influence the development of the capsular
fibrosis. In order to mask the silicone in the phase of wound healing and
present the body with a natural biocompatible protein instead of silicone, a
novel silk coating has been developed.
Female subjects are wishing a breast augmentation with silicone-based breast
implants in general. In all operations, especially any kind of implantations of
silicone based implants adverse effects and complaints are expected. Based on
the previous investigations (Pre-clinical), it is not to be assumed, that the
silk-coating will cause additional risks.
Altheimer Strasse 32
Dieburg 64807
DE
Altheimer Strasse 32
Dieburg 64807
DE
Listed location countries
Age
Inclusion criteria
1. Female and at least 18 years of age.
2.Seeking primary breast augmentation. The
size of the requested device for subject*s
breast augmentation is between 240 mL
and 400 mL. 3. Written informed consent
after being informed of the study procedure
and risks, prior to any study-related events.
4. Good general state of health (mentally
and physically). Laboratory parameters and
vital signs not showing any clinically
significant abnormalities. 5. Able to
undergo general anesthesia and subject is
a suitable surgical candidate. 6. Willing and
able to return to a study site for postprocedural
follow-up examinations.
Exclusion criteria
1. Pregnancy. 2. Female subjects of
childbearing capacity who are not willing to
employ a highly effective contraceptive
measure for the duration of the clinical
study (i.e. double barrier method combined
with hormonal contraceptives or intrauterine
device, total abstinence). 3. Breast feeding
women or less than 6 months after stopping
breast feeding. 4. Breast reconstruction or
augmentation history. 5. Previous silicone
implants. 6. Known genetic or familial
predisposition to breast cancer. 7. Known
abscesses, cysts or tumors in the area of
implants, advanced fibrocystic diseases. 8.
Existing costal injuries 9. Clinically
significant diagnosis of any severe acute or
chronic illness such as oncological
diseases, autoimmune diseases, wound
healing disorders, diabetes mellitus. 10.
Positive human immunodeficiency virus,
hepatitis B or C test result. 11. Heavy burn
scars or insufficient tissue covering in the
prospective area of implantation. 12.
Subjects not willing to refrain from
recreational drugs. 13. Continuous intake of
drugs acting on the central nervous system
e.g. antidepressants, antiepileptics,
sedatives. 14. Known or suspected allergy,
intolerance or adverse reaction to
antibiotics, anesthetics and/or products
used during the surgery. 15. Subjects who
are currently participating or who have
participated in any other clinical trial within
60 days prior to enrollment and subjects
who are not willing to refrain from
participation in any other clinical trial during
the participation in this study. 16. Subjects
who are unable to comply with the Clinical
Investigation Plan requirements. 17.
Employees of the sponsor or subjects who
are employees or relatives of the
investigator.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL66894.029.18 |