RecruitingInterventional

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

NCT ID: NCT04967976Sponsor: Tianjin Medical University Cancer Institute and HospitalLast updated: 2021-07-20

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.

Arms & interventions

ProcedureTiLoop 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.
Proceduresub-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.

Outcome measures

Primary

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

Secondary

number of revision surgery
Time frame: from the completion of expander exchange up to 24 months after surgery
aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire
Time frame: from the completion of expander exchange up to 24 months after surgery
psychological evaluation by Breast-Q questionnaire
Time frame: from the completion of expander exchange up to 24 months after surgery
total cost
Time frame: from expander implation up to the completion of expander exchange,through study completion, an average of 1 year
number of occurrence of deep venous thrombosis
Time frame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
number of occurrence of non-surgical site infection
Time frame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year

Eligibility criteria

Sex: FemaleAge: 18 Years to 70 YearsHealthy volunteers: No

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 locations (1)

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Edward Chang · Contact