Breast Mesh Used in Two-staged Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967976
• Other study ID #: E20210210
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: April 2021
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jian Yin
• Phone: +86-22-23340123
• Email: yinjian[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast Reconstruction
• Radiation

Intervention

Procedure:
• TiLoop Bra mesh in expander-implant breast reconstrution
The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.
• sub-pectoral expander-implant breast reconstruction
The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

Locations

Country	Name	City	State
China	Jilin Cancer Hospital	Ch'ang-ch'un	Jilin
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Gansu Provincial Cancer Hospital	Lanzhou	Gansu
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
Germany	Technical University of Munich	Munich
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Countries where clinical trial is conducted

United States,  China,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rates	complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.	up to 24 months after surgery
Primary	Expansion Efficiency	percentage of average injected saline volume to total volume (E=average volume/ total volume)through study completion, an average of 1 year	through study completion, an average of 1 year
Secondary	number of revision surgery	To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation,	from the completion of expander exchange up to 24 months after surgery
Secondary	aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire	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.	from the completion of expander exchange up to 24 months after surgery
Secondary	psychological evaluation by Breast-Q questionnaire	We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.	from the completion of expander exchange up to 24 months after surgery
Secondary	total cost	total cost in RMB per captia	from expander implation up to the completion of expander exchange,through study completion, an average of 1 year
Secondary	number of occurrence of deep venous thrombosis	post-operative occurrence of deep venous thrombosis	from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
Secondary	number of occurrence of non-surgical site infection	post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc.	from expander implation up to the completion of expander exchange, through study completion, an average of 1 year