Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
NCT05888571

Pre-pectoral Breast Reconstruction With or Without Mesh

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-01-31

164

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To explore the efficacy and safety that occur after immediate prepectoral breast reconstruction when TiLOOP Mesh is used compared to that when TiLOOP Mesh is not used.

CONDITIONS

Official Title

Pre-pectoral Breast Reconstruction With or Without Mesh

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult women aged 18-65 years planning unilateral or bilateral immediate prepectoral prosthesis breast reconstruction
  • Undergoing skin-sparing, nipple-sparing, or skin-reducing mastectomy for breast cancer or prophylactic mastectomy
  • Tissue expander size less than or equal to 800cc, implant size less than or equal to 600cc
  • Good blood perfusion of the breast skin flap
  • Non-smoker for at least 4 weeks prior to surgery
  • Normal expectations and mental health regarding breast reconstruction
  • Signed consent to participate
Not Eligible

You will not qualify if you...

  • Poor perfusion of breast mastectomy flap
  • Patients undergoing second stage breast reconstruction
  • History of chest radiotherapy
  • Body mass index (BMI) greater than 35
  • Smoking within the last 4 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

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Research Team

J

Jian Yin

CONTACT

C

Chunyong Han

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Pre-pectoral Breast Reconstruction With or Without Mesh | DecenTrialz