The aim of this study is to identify Galectin-1 and -3 as possible biomarkers in capsular contracture. Moreover, we plan to investigate whether HLA-typing and IgE levels in subjects can be used to predict the chance of development of capsular…
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum and local Galectin-1, -3, HLA and IgE
Secondary outcome
Not applicable.
Background summary
Silicone implants have been used in breast augmentation mammoplasty and in
reconstruction following mastectomy. Capsular contracture is the most common
complication and most frequent cause for reoperation after implant placement.
To date, the cause of capsular contracture is unknown. One of the etiologic
pathways described in literature is low-grade chronic inflammation caused by a
foreign-body reaction or low-grade infection. Furthermore, it has been recently
suggested that there is an association between local and systemic
complications. Therefore, the severity of capsular contracture may be used as a
diagnostic marker to identify unexplained systemic complications probably
related to silicone. Currently, local complications are objectified through
physical examination and graded by the Baker scale. The Baker grading is an
esthetic outcome measurement, but does not provide information on the extent of
fibrosis around silicone implants. Association between the biomarker Galectin-3
levels and various types of fibrosis has been demonstrated recently in the
literature. We therefore postulate, since the pathogenesis of capsular
contracture may be quite similar to that of other fibrotic disorders, that
Galectin-3 can be objectively used as a biomarker to assess the severity of
capsular contracture in patients with silicone implants. Moreover, Galectin-1
has been found in angiogenetic processes in the body, which might be similar to
capsular contracture. Therefore, we suggest that Galectin-1 can indicate the
degree of fibrosis in capsules around breast implants. Moreover, foreign-body
mediators such as Human Leucocyte Antigen (HLA) and Immunoglubulin E (IgE) may
provide important information on genetic susceptibility and atopic constitution
which may enhance the chance to develop capsular contracture.
Study objective
The aim of this study is to identify Galectin-1 and -3 as possible biomarkers
in capsular contracture. Moreover, we plan to investigate whether HLA-typing
and IgE levels in subjects can be used to predict the chance of development of
capsular contracture in the future
Study design
The study is a cross-sectional pilot study
Study burden and risks
There is no risk involved in participation and the burden associated with
participation is very small. One venous blood sample will be collected as well
as the breast capsule which will be removed during surgery. All participants
will be asked to fill in a short questionnaire about capsular contracture.
Background and clinical data is acquired by retrospective analysis of the
patient files. Participants will be informed about the purpose of this research
and are free to refuse participation.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- females aged 18 or over
- females who have developed capsular contracture (Baker score 1&2 and 3&4) after bilateral cosmetic breast augmentation with silicone breast implants at least one year after implant implantation
- females who who are on the waiting list for a breast augmentation will serve as a control group
Exclusion criteria
- females who have a co-morbidity (e.g. diseases of the liver, lung, heart, kidney, or skin);
- females who have (a history of) cancer
- females who have a capsular contracture for more than 5 years
- females who have had silicone injections
- females who are currently smoking or smoked in the past year
Design
Recruitment
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 | NL50729.029.14 |