Pre-pectoral Breast Reconstruction With or Without Mesh
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Poor perfusion of breast mastectomy flap;
II stage breast reconstruction patients;
History of chest radiotherapy;
BMI greater than 35;
Trial design
Design model
Parallel
Treatments tested in this trial
prepectoral breast reconstruction
Procedure/SurgeryPatients receive immediate prepectoral breast reconstruction
Tiloop Mesh implantation
Procedure/SurgeryPatients receive immediate prepectoral breast reconstruction with Tiloop Mesh
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: prepectoral breast reconstruction with MeshActive comparator 2 interventions
Group B: prepectoral breast reconstruction without MeshExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Major Complication Rates
The rate of major complications in the two groups
Time frame
up to 12 months after surgery2
Patient Breast-Q questionnaire
We use the Breast-Q questionnaire to evaluate patients' satisfaction via the reconstruction module of BREAST-Q.
Time frame
up to 12 months after surgerySecondary outcomes
1
Minor Complication Rates
The rate of minor complications in the two groups
Time frame
up to 12 months after surgery2
Rates of capsule contracture
The rates of capsule contracture in the two groups
Time frame
up to 24 months after surgery3
The rate of surgical revision of reconstructed breasts
To record the rate of surgical revision events of the reconstructed breasts
Time frame
up to 12 months after surgery4
The rate of implant or tissue expander removal
The rate of implant or tissue expander removal in the two groups
Time frame
up to 12 months after surgerySponsors and contacts
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Source ClinicalTrials.gov