Primary Objective: to determine whether polyurethane covered silicone implants (PCI) give a different capsular contracture rate than textured silicone implants (TI) in two-stage implant breast reconstruction after mastectomy in women.Secondary…
ID
Source
Brief title
Condition
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is capsular contracture. This is a clinical diagnosis
classified in the modified Baker classification, which allows for correct
interpretation of capsular contracture in a reconstructed breast. Baker grade 3
or 4 capsular contractures are considered clinically relevant. A breast with a
grade 3 contracture feels and looks moderately firm, but this firmness is still
compatible with an acceptable outcome, although the patient may be
dissatisfied. Reoperation is not necessarily required. Grade 4 represents an
excessively firm reconstructed breast, resulting in a poor aesthetic result
and/or significant patient symptoms such as pain. Surgical intervention is
required.
Secondary outcome
- Other complications: e.g. cutaneous rash, hematoma, seroma, infection, skin
necrosis, implant rupture, malposition, exposure, and visibility/palpability.
Also, explantation is registered together with its indication.
- Quality of life and patient satisfaction
- Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
- User-friendliness of PCI*s
Background summary
Two-step implant-based breast reconstruction is a common reconstructive
technique after mastectomy. It is associated with some implant specific
complications. Capsular contracture is a complication which develops when
internal scar tissue forms a tight or constricting capsule around a breast
implant, contracting it until it becomes misshapen and hard. As a result, the
breast may feel painful and stiff, and the capsule may affect the appearance or
shape of the breast. On average one out of every six patients has developed a
capsular contracture after 10 years. Much of the etiology is still unknown, but
there are indications which suggest influence of the outer surface of the
implant. Compared to smooth implants, textured implants show lower capsular
contracture rates. Based on the current literature we hypothesize that
polyurethane-covered implants reduce or delay the development of capsular
contracture compared to textured implants.
Study objective
Primary Objective: to determine whether polyurethane covered silicone implants
(PCI) give a different capsular contracture rate than textured silicone
implants (TI) in two-stage implant breast reconstruction after mastectomy in
women.
Secondary Objectives: to compare revision surgery rate, complication rates,
patient satisfaction, user friendliness and long-term patient safety between
PCI*s and TI*s.
Study design
Multicenter, prospective, open-label, randomized controlled trial
Intervention
Patients in both cohorts will receive a two-step implant-based breast
reconstruction after mastectomy. In the second step of the breast
reconstruction procedure a definite implant is placed. These will differ for
the cohorts: our intervention cohort will receive a polyurethane covered
implant and the control cohort will receive a standard textured implant.
Study burden and risks
The is no definite proof in the current literature whether polyurethane covered
implants reduce the risk of capsular contracture in our study population. We
hypothesize that polyurethane covered implants have a lower capsular
contracture rate. Patients in the intervention cohort might benefit with a
lower risk of capsular contracture or delayed development of capsular
contracture. However, this is no certainty.
There are no known additional risks with using polyurethane covered implants
for breast reconstruction. The burden of this study for the participants
comprises of the screening consultation and three extra outpatient clinic
visits and the requirement to fill out three questionnaires at seven moments
during the course of this study. These are health surveys. We believe this is
proportional to the academic worth of the study results.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
• Female
• Age of 18 years or older
• Mastectomy is performed
• Eligible for two-stage implant-based breast reconstruction in accordance with
the Dutch national breast reconstruction guideline
• First step of two-stage implant-based breast reconstruction (placement of
tissue expander) is successfully completed
• Able to understand the patient information sheet, to complete questionnaires
and to provide written informed consent
Exclusion criteria
• Additional use of autologous tissues for the breast reconstruction
• The use of acellular dermal matrix or synthetic mesh
• Prior irradiation of the breast or an indication for postoperative
radiotherapy (If a patient receives radiotherapy unexpectedly at a later point
in time, she will be excluded retroactively)
• Secondary reconstruction
• Revision surgery of a previous breast reconstruction
• Inflammatory carcinoma
• Evidence of distant metastases
• Active infection at the surgical field or distant locations
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 | NL63959.078.18 |