Clinical trial NCT04967976: Breast Mesh Used in Two-staged Breast Reconstruction
Official title: A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Radiation
Breast Reconstruction
Synthetic Mesh
Keywords: breast cancer
breast reconstruction
radiation
synthetic mesh
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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   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

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Primary outcomes:
measure: Complication Rates
timeFrame: up to 24 months after surgery
measure: Expansion Efficiency
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: number of revision surgery
timeFrame: from the completion of expander exchange up to 24 months after surgery
measure: aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire
timeFrame: from the completion of expander exchange up to 24 months after surgery
measure: psychological evaluation by Breast-Q questionnaire
timeFrame: from the completion of expander exchange up to 24 months after surgery
measure: total cost
timeFrame: from expander implation up to the completion of expander exchange,through study completion, an average of 1 year
measure: number of occurrence of deep venous thrombosis
timeFrame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
measure: number of occurrence of non-surgical site infection
timeFrame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
state: Gansu
city: Ch'ang-ch'un
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Munich
country: Germany
facility: Technical University of Munich
Study officials:
References: