RecruitingNot ApplicableNCT05888571
Pre-pectoral Breast Reconstruction With or Without Mesh
A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Mesh
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Enrollment
164 participants
Start Date
Jul 1, 2023
Study Type
INTERVENTIONAL
Conditions
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: FEMALEMin Age: 18 YearsMax Age: 65 Years
Inclusion Criteria7
- Adult women aged 18-65 years who plan to undergo unilateral or bilateral immediate prepectoral prothesis breast reconstruction;
- SSM or NSM or Skin-Reducing Mastectomy for breast cancer patients or prophylactic mastectomy;
- Tissue expander size =\<800cc, implant size =\<600cc;
- The blood perfusion of breast skin flap was well;
- Do not smoking in the last 4 weeks or more
- Patients with normal expectations and mental health for breast reconstruction;
- Signed consent to participate
Exclusion Criteria5
- Poor perfusion of breast mastectomy flap;
- II stage breast reconstruction patients;
- History of chest radiotherapy;
- BMI greater than 35;
- Patients who have not quit smoking within the last 4 weeks;
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Interventions
PROCEDUREprepectoral breast reconstruction
Patients receive immediate prepectoral breast reconstruction
PROCEDURETiloop Mesh implantation
Patients receive immediate prepectoral breast reconstruction with Tiloop Mesh
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05888571