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Clinical Trials/NCT04967976
NCT04967976RecruitingNot Applicable

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

Tianjin Medical University Cancer Institute and Hospital7 sites in 3 countries300 target enrollmentStarted: August 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
7
Primary Endpoint
Complication Rates
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Patients with distant metastasis of breast cancer or local recurrence;
  • •Past ipsilateral breast/chest wall radiation;
  • •Inflammatory breast cancer, stage IV breast cancer
  • •History of severe allergic or specific constitution;
  • •Mental illness;
  • •Drug/alcohol abuse;
  • •Pregnancy, lactation, or impregnated during the trial period;
  • •Non-eligible to the study enrollment based on researchers' discretion

Outcomes

Primary Outcomes

Complication Rates

Time Frame: up to 24 months after surgery

complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.

Expansion Efficiency

Time Frame: through study completion, an average of 1 year

percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year

Secondary Outcomes

  • 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)
  • number of occurrence of non-surgical site infection(from expander implation up to the completion of expander exchange, through study completion, an average of 1 year)
  • number of revision surgery(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)
  • aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (7)

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