Breast Mesh Used in Two-staged Breast Reconstruction

Part of paid clinical trials in Houston, Texas.

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT04967976
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TiLoop Bra mesh in expander-implant breast reconstrution — PROCEDURE
    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.
  • sub-pectoral expander-implant breast reconstruction — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2021
Status verified
Apr 2021
Primary completion
Aug 1, 2023
Completion
Aug 1, 2026

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Breast Reconstruction with breast mesh
    The tissue expander-implant reconstruction with TiLoop Bra mesh.
  • Active Comparator: Breast Reconstruction without breast mesh
    The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

Primary Outcome Measure

Complication Rates [ Time Frame: up to 24 months after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Edward Chang

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
MD Anderson Cancer Center· Houston, TX

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