ong-term results of two-stage breast reconstruction with polyurethane-covered versus textured implants: a prospective, multicenter randomized controlled trial

Recruiting

Conditions: breast implant hardening
capsular contracture
capsule contracture
10006295

Registration Number: NL-OMON50674

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 321

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is capsular contracture. This is a clinical diagnosis<br /><br>classified in the modified Baker classification, which allows for correct<br /><br>interpretation of capsular contracture in a reconstructed breast. Baker grade 3<br /><br>or 4 capsular contractures are considered clinically relevant. A breast with a<br /><br>grade 3 contracture feels and looks moderately firm, but this firmness is still<br /><br>compatible with an acceptable outcome, although the patient may be<br /><br>dissatisfied. Reoperation is not necessarily required. Grade 4 represents an<br /><br>excessively firm reconstructed breast, resulting in a poor aesthetic result<br /><br>and/or significant patient symptoms such as pain. Surgical intervention is<br /><br>required. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Other complications: e.g. cutaneous rash, hematoma, seroma, infection, skin<br /><br>necrosis, implant rupture, malposition, exposure, and visibility/palpability.<br /><br>Also, explantation is registered together with its indication.<br /><br>- Quality of life and patient satisfaction<br /><br>- Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)<br /><br>- User-friendliness of PCI*s</p><br>