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OpenTrials
Enrolling by Invitation

NCT Number: NCT07419971

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

The aim of this study is to evaluate the aesthetic outcomes in immediate implant-based breast reconstruction following breast mastectomy surgery.

Enrolling by Invitation

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

West China Hospital

Chengdu, Sichuan, 610000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

synthetic mesh

Procedure

Whether synthetic meshes are used in breast cancer patients for immediate breast reconstruction after breast cancer resection

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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