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

Long-term results of two-stage breast reconstruction with polyurethane-covered versus textured implants: a prospective, multicenter randomized controlled trial - TIPI TRAIL: Textured Implants versus Polyurethane-covered Implants

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50674

Enrollment

321

Registered

2018-09-25

Start date

2019-02-25

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast implant hardening capsular contracture capsule contracture

Interventions

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 w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
- 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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)