Breast Mesh Used in Two-staged Breast Reconstruction
A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
1 other identifier
interventional
300
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Aug 2021
Longer than P75 for not_applicable breast-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
July 20, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedJuly 20, 2021
April 1, 2021
2 years
June 10, 2021
July 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (6)
number of revision surgery
from the completion of expander exchange up to 24 months after surgery
aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire
from the completion of expander exchange up to 24 months after surgery
psychological evaluation by Breast-Q questionnaire
from the completion of expander exchange up to 24 months after surgery
total cost
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
from expander implation up to the completion of expander exchange, through study completion, an average of 1 year
- +1 more secondary outcomes
Study Arms (2)
Breast Reconstruction with breast mesh
EXPERIMENTALThe tissue expander-implant reconstruction with TiLoop Bra mesh.
Breast Reconstruction without breast mesh
ACTIVE COMPARATORThe tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Diagnosed with breast cancer
- More than 18 years old
- Karnofsky Performance Status (KPS) larger than 80
- No clinical or imaging evidence of distant metastasis
- BMI \< 35kg/m2
- Patients with no or mild breast ptosis
- No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
- Mental Health Patient
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Jilin Cancer Hospital
Ch’ang-ch’un, Jilin, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Technical University of Munich
Munich, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2021
First Posted
July 20, 2021
Study Start
August 1, 2021
Primary Completion
August 1, 2023
Study Completion (Estimated)
August 1, 2026
Last Updated
July 20, 2021
Record last verified: 2021-04