Breast Mesh Used in Two-staged Breast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Diagnosed with breast cancer
More than 18 years old
Karnofsky Performance Status (KPS) larger than 80
No clinical or imaging evidence of distant metastasis
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
TiLoop Bra mesh in expander-implant breast reconstrution
Procedure/SurgeryThe 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
Procedure/SurgeryThe 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Breast Reconstruction with breast meshExperimental treatment 1 intervention
Group B: Breast Reconstruction without breast meshActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 surgery2
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 yearSecondary outcomes
1
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,
Time frame
from the completion of expander exchange up to 24 months after surgery2
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.
Time frame
from the completion of expander exchange up to 24 months after surgery3
psychological evaluation by Breast-Q questionnaire
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
Time frame
from the completion of expander exchange up to 24 months after surgery4
total cost
total cost in RMB per captia
Time frame
from expander implation up to the completion of expander exchange,through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov