Influencing Factors and Mechanisms of Capsular Contracture After Prosthesis Reconstruction in Patients With Breast Cancer

March 15, 2026 updated by: Qing LYU, West China Hospital
The aim of this study is to evaluate the aesthetic outcomes in immediate implant-based breast reconstruction following breast mastectomy surgery.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patients who undergoing mastectomy and the implant- based breast reconstruction for breast cancer or prophylactic reasons

Description

Inclusion Criteria: Female adults aged 18 years or older; Undergoing mastectomy for breast cancer or prophylactic reasons; Receiving immediate implant-based reconstruction (either implant-only or combined with an autologous flap) Exclusion Criteria: Delayed reconstruction; Purely autologous reconstruction (without an implant); Incomplete postoperative follow-up data precluding effective aesthetic assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mesh
implant- based breast reconstruction with synthetic mesh
Procedure: synthetic mesh
Whether synthetic meshes are used in breast cancer patients for immediate breast reconstruction after breast cancer resection
Without Mesh
implant- based breast reconstruction without synthetic mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic Outcome
Time Frame: From enrollment to the end of follow up at 6 months
Half a year post-IBBR, patients underwent a structured interview and physical examination by two independent senior breast surgeon, blinded to the surgical details, during outpatient visits using the Ueda Aesthetic Scale, "Excellent'" (9-10 points), ''Good'' (7-8points), ''Fair'' (5-6 points) and ''Poor'' (0-4 points).
From enrollment to the end of follow up at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 15, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-766

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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