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NCT Number: NCT04967976

Breast Mesh Used in Two-staged Breast Reconstruction

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Reconstruction Neoplasms Neoplasms by Site Radiation Skin Diseases Skin and Connective Tissue Diseases Synthetic Mesh

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gansu Provincial Cancer Hospital, Lanzhou, Gansu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with breast cancer
  • More than 18 years old
  • Karnofsky Performance Status (KPS) larger than 80
  • No clinical or imaging evidence of distant metastasis
  • BMI < 35kg/m2
  • Patients with no or mild breast ptosis
  • No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
  • Mental Health Patient

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Exclusion criteria

  • Patients with distant metastasis of breast cancer or local recurrence; 2. Past ipsilateral breast/chest wall radiation; 3. Inflammatory breast cancer, stage IV breast cancer 4. History of severe allergic or specific constitution; 5. Mental illness; 6. Drug/alcohol abuse; 7. Pregnancy, lactation, or impregnated during the trial period; 8. Non-eligible to the study enrollment based on researchers' discretion

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Treatment and study plan

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.

Primary outcomes

  1. Complication Rates

    Time frame: up to 24 months after surgery

    complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.

  2. Expansion Efficiency

    Time frame: through study completion, an average of 1 year

    percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year

Secondary outcomes

  1. number of revision surgery

    Time frame: from the completion of expander exchange up to 24 months after surgery

    To record the rate of surgical revision events on the breast including but not limited to fat tranplantation, reduction mammoplasty/mastompexy, contralateral augmentation,

  2. aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire

    Time frame: from the completion of expander exchange up to 24 months after surgery

    Harris evaluation score was used to evaluate the aesthetic outcome of patients' reconstructed breasts, which was scored as "excellent," "good," "fair," "poor".

    Breast-Q questionaire was also used to evaluate the aesthetic outcome of patients' reconstructed breast.

  3. psychological evaluation by Breast-Q questionnaire

    Time frame: from the completion of expander exchange up to 24 months after surgery

    We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.

  4. total cost

    Time frame: from expander implation up to the completion of expander exchange,through study completion, an average of 1 year

    total cost in RMB per captia

  5. number of occurrence of deep venous thrombosis

    Time frame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year

    post-operative occurrence of deep venous thrombosis

  6. number of occurrence of non-surgical site infection

    Time frame: from expander implation up to the completion of expander exchange, through study completion, an average of 1 year

    post-operative occurrence of non-surgical site infection including but not limited pneumonia, urinary tract infection, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Bowen Ding

CONTACT

[email protected]

+86-22-23340123 ext. 1171

Jian Yin

CONTACT

[email protected]

+86-22-23340123 ext. 1174

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Jul 20, 2021
Registry last updated
Jul 20, 2021

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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