A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country164 target enrollmentJuly 1, 2023

ConditionsPrepectoral Breast Reconstruction TiLOOP Mesh

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prepectoral Breast Reconstruction
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 164
Locations: 1
Primary Endpoint: Major Complication Rates
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 1, 2023

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
•SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
•Tissue expander size =\<800cc, implant size =\<600cc;
•The blood perfusion of breast skin flap was well;
•Do not smoking in the last 4 weeks or more
•Patients with normal expectations and mental health for breast reconstruction;
•Signed consent to participate

Exclusion Criteria

•Poor perfusion of breast mastectomy flap;
•II stage breast reconstruction patients;
•History of chest radiotherapy;
•BMI greater than 35;
•Patients who have not quit smoking within the last 4 weeks;

Outcomes

Primary Outcomes

Major Complication Rates

Time Frame: up to 12 months after surgery

The rate of major complications in the two groups

Patient Breast-Q questionnaire

Time Frame: up to 12 months after surgery

We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.

Secondary Outcomes

Minor Complication Rates(up to 12 months after surgery)
The rate of surgical revision of reconstructed breasts(up to 12 months after surgery)
Rates of capsule contracture(up to 24 months after surgery)
The rate of implant or tissue expander removal(up to 12 months after surgery)