Breast Mesh Used in Two-staged Breast Reconstruction

Not Applicable

Recruiting

• Conditions: Breast Cancer; Radiation; Breast Reconstruction; Synthetic Mesh
• Interventions: Procedure: TiLoop Bra mesh in expander-implant breast reconstrution; Procedure: sub-pectoral expander-implant breast reconstruction

• Registration Number: NCT04967976
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20
• Study Start: 2021-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. Diagnosed with breast cancer

2. More than 18 years old

3. Karnofsky Performance Status (KPS) larger than 80

4. No clinical or imaging evidence of distant metastasis

5. BMI < 35kg/m2

6. Patients with no or mild breast ptosis

7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.

8. Mental Health Patient

Exclusion Criteria

1. Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast Reconstruction with breast mesh	TiLoop Bra mesh in expander-implant breast reconstrution	The tissue expander-implant reconstruction with TiLoop Bra mesh.
Breast Reconstruction without breast mesh	sub-pectoral expander-implant breast reconstruction	The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

Primary Outcome Measures

Name	Time	Method
Complication Rates	up to 24 months after surgery	complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
Expansion Efficiency	through study completion, an average of 1 year	percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
number of occurrence of deep venous thrombosis	from expander implation up to the completion of expander exchange, through study completion, an average of 1 year	post-operative occurrence of deep venous thrombosis
number of occurrence of non-surgical site infection	from expander implation up to the completion of expander exchange, through study completion, an average of 1 year	post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc.
number of revision surgery	from the completion of expander exchange up to 24 months after surgery	To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation,
aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire	from the completion of expander exchange up to 24 months after surgery	Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor".; Breast-Q questionaire was also used to evaluate the aesthetic outcome of patients' reconstructed breast.
psychological evaluation by Breast-Q questionnaire	from the completion of expander exchange up to 24 months after surgery	We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
total cost	from expander implation up to the completion of expander exchange,through study completion, an average of 1 year	total cost in RMB per captia

Trial Locations

Locations (6)

Gansu Provincial Cancer Hospital; 🇨🇳 Lanzhou, Gansu, China

Jilin Cancer Hospital; 🇨🇳 Ch'ang-ch'un, Jilin, China

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

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

Technical University of Munich; 🇩🇪 Munich, Germany

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States