Prepectoral Breast Reconstruction, TiLOOP Mesh
Conditions
Brief summary
To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.
Detailed description
The clinical study aims to explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that not using TiLOOP Mesh.
Interventions
PROCEDUREprepectoral breast reconstruction
Patients receive immediate prepectoral breast reconstruction
PROCEDURETiloop Mesh implantation
Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction; 2. SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy; 3. Tissue expander size =\<800cc, implant size =\<600cc; 4. The blood perfusion of breast skin flap was well; 5. Do not smoking in the last 4 weeks or more 6. Patients with normal expectations and mental health for breast reconstruction; 7. Signed consent to participate
Exclusion criteria
1. Poor perfusion of breast mastectomy flap; 2. II stage breast reconstruction patients; 3. History of chest radiotherapy; 4. BMI greater than 35; 5. Patients who have not quit smoking within the last 4 weeks;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Complication Rates | up to 12 months after surgery | The rate of major complications in the two groups |
| Patient Breast-Q questionnaire | up to 12 months after surgery | We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minor Complication Rates | up to 12 months after surgery | The rate of minor complications in the two groups |
| Rates of capsule contracture | up to 24 months after surgery | The rates of capsule contracture in the two groups |
| The rate of surgical revision of reconstructed breasts | up to 12 months after surgery | To record the rate of surgical revision events of the reconstructed breasts |
| The rate of implant or tissue expander removal | up to 12 months after surgery | The rate of implant or tissue expander removal in the two groups |
Countries
China
Contacts
Primary ContactJian Yin
Backup ContactChunyong Han
Outcome results
None listed