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Breast Mesh Used in Two-staged Breast Reconstruction

NCT04967976 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-07-20

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

TiLoop 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.

PROCEDURE

sub-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.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2023-08-01
Completion
2026-08-01

Countries

  • United States
  • China
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04967976 on ClinicalTrials.gov