Tianjin Medical University Cancer Institute and Hospital
Phase
Not applicable
Started
2023-07-01
Last updated
2024-01-31
Condition(s) studied
Prepectoral Breast ReconstructionTiLOOP Mesh
Investigational drug(s) / intervention(s)
prepectoral breast reconstructionTiloop Mesh implantation
prepectoral breast reconstruction: Patients receive immediate prepectoral breast reconstruction
Tiloop Mesh implantation: Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
2. SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
3. Tissue expander size =\<800cc, implant size =\<600cc;
4. The blood perfusion of breast skin flap was well;
5. Do not smoking in the last 4 weeks or more
6. Patients with normal expectations and mental health for breast reconstruction;
7. Signed consent to participate
Exclusion Criteria:
1. Poor perfusion of breast mastectomy flap;
2. II stage breast reconstruction patients;
3. History of chest radiotherapy;
4. BMI greater than 35;
5. Patients who have not quit smoking within the last 4 weeks;
Primary outcome measure(s)
Major Complication Rates — up to 12 months after surgery The rate of major complications in the two groups
Patient Breast-Q questionnaire — up to 12 months after surgery We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Tianjin Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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