Breast Mesh Used in Two-staged Breast Reconstruction

Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04967976
Collaborator
(none)
300
6
2
60
50
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TiLoop Bra mesh in expander-implant breast reconstrution
  • Procedure: sub-pectoral expander-implant breast reconstruction
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Breast Reconstruction with breast mesh

The tissue expander-implant reconstruction with TiLoop Bra mesh.

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.

Active Comparator: Breast Reconstruction without breast mesh

The tissue expander-implant reconstruction without TiLoop Bra mesh. The tissue expander is placed sub-pectoral and covered by muscle/fascia.

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.

Outcome Measures

Primary Outcome Measures

  1. Complication Rates [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 [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 Outcome Measures

  1. number of revision surgery [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Diagnosed with breast cancer

  2. More than 18 years old

  3. Karnofsky Performance Status (KPS) larger than 80

  4. No clinical or imaging evidence of distant metastasis

  5. BMI < 35kg/m2

  6. Patients with no or mild breast ptosis

  7. No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.

  8. Mental Health Patient

Exclusion Criteria:
  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MD Anderson Cancer Center Houston Texas United States 77030
2 Gansu Provincial Cancer Hospital Lanzhou Gansu China
3 Jilin Cancer Hospital Ch'ang-ch'un Jilin China
4 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060
5 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China
6 Technical University of Munich Munich Germany

Sponsors and Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT04967976
Other Study ID Numbers:
  • E20210210
First Posted:
Jul 20, 2021
Last Update Posted:
Jul 20, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tianjin Medical University Cancer Institute and Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021