Pre-pectoral Breast Reconstruction With or Without Mesh

Tianjin Medical University

Status: Enrolling

Conditions: Prepectoral Breast Reconstruction; TiLOOP Mesh

Treatments: Procedure: Tiloop Mesh implantation; Procedure: prepectoral breast reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT05888571

E20230013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

prepectoral breast reconstruction with Mesh

Active Comparator group

Description:

Immediate prepectoral breast reconstruction with Mesh

Treatment:

Procedure: Tiloop Mesh implantation

Procedure: prepectoral breast reconstruction

prepectoral breast reconstruction without Mesh

Experimental group

Description:

Immediate prepectoral breast reconstruction without Mesh

Treatment:

Procedure: prepectoral breast reconstruction