Pre-pectoral Breast Reconstruction With or Without Mesh

Not Applicable

Recruiting

• Conditions: Prepectoral Breast Reconstruction; TiLOOP Mesh
• Interventions: Procedure: prepectoral breast reconstruction; Procedure: Tiloop Mesh implantation

• Registration Number: NCT05888571
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-05
• Study Start: 2023-07-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 164

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prepectoral breast reconstruction with Mesh	Tiloop Mesh implantation	Immediate prepectoral breast reconstruction with Mesh
prepectoral breast reconstruction with Mesh	prepectoral breast reconstruction	Immediate prepectoral breast reconstruction with Mesh
prepectoral breast reconstruction without Mesh	prepectoral breast reconstruction	Immediate prepectoral breast reconstruction without Mesh

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Rates of capsule contracture	up to 24 months after surgery	The rates of capsule contracture in the two groups
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
Minor Complication Rates	up to 12 months after surgery	The rate of minor complications in the two groups

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China