Fat grafting e.g. to the breast to restore small tissue defects is a very common and safe surgical procedure. Its main success among other is depended on the survival rate of the transferred fat tissue. The survival rate is very unpredictable and varies from 16-70%. This study will examine impact of autologous PRP-Lysate as a enrichment to fat grafts with the assumption to enhance the survival rate. MedDRA version: 20.0 Level: PT Classification code 10016251 Term: Fat tissue increased System Or
Conditions
Interventions
Product Name: aPL
Product Code: aPL
Pharmaceutical Form: Concentrate for solution for injection
Other descriptive name: PLATELET CONCENTRATE
Concentration unit: % (V/V) percent volume/volume
Concentra
Sponsors
Medical University of Vienna, Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Female age 18 to 45 -BMI between 21-28 -Candidate for bilateral primary breast augmentation – wish to augment breasts -Breast cup size at least B -Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, no history of severe claustrophobia) -Sufficient knowledge of German or English language to understand trial instructions and ability to comply with treatment -The patient has realistic expectations of surgical results after discussion with investigator and is an acceptable candidate for breast augmentation towards investigator judgment -Adequate peripheral vein status for pheresis -Written on informed consent prior to enrolment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -History or current diagnosis of breast cancer -Women undergoing reconstructive surgery following mastectomy -History of cancer (except non-melanoma skin cancer, or carcinoma in situ of cervix) within the previous two years -Pregnancy or breast feeding at time of screening -Patients with scarred breast tissue, with breast size asymmetry reflected in different breast holder size cups -Women with current infection requiring systemic antibiotic treatment -Known alcohol, drug or medication abuse -The patient participated in an interventional trial within 90 days of enrolment -The patient has a severe breast and upper trunk deformity -The patients is not willing to undergo further surgery for revision, if medically required -Use of any immunosuppresive or immunomodulatiry treatment, chronic use of oral or systemic anticoagulation or antiplatelet therapy -Patients with platelet disorders, thrombocytopenia, bone marrow aplasia -Any clinically relevant concomitant condition that could compromise the objectives of this study and/ or the patient’s compliance (eg. Patients with diabetes mellitus under treatment, end-stage renal disease and patients on dialysis, patients with severe cardiovascular condition requiring chronic treatment) -Laboratory criteria: hemoglobin 5mg/dl, platelets 400 tsd./µl, leucocytes 11,3 tsd./µl -Blood donation within 4 weeks before study initiation -Patients with connective tissue disease OR is currently being evaluated for symptoms suggestive of connective tissue disease -Any other condition the investigator believes would interfere with the patient’s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate efficacy of enrichment of fat grafts with autologous platelet lysate to enhance the fat graft take potential in women with breast augmentation.;Secondary Objective: To assess the safety of autologous platelet-lysate enriched fat graft in women with breast augmentation To evaluate if the addition of autologous platelet-lysate enriched fat graft will reduce the incidence of fat necrosis, cyst formation and nodules in women with breast augmentation To evaluate the effect of autologous platelet-lysate enriched fat graft on the patient reported quality of life;Primary end point(s): Breast volume measurement with MRI is a surrogate of fat survival rate. Since interest lies in the clinical relevance of the new treatment, statistical analysis will be performed primarily by the intention-to-treat principle and secondarily by the per-protocol principle. A zero change in fat-survival rate will be imputed for non-available measurements. Main outcome parameter is the fat-survival rate at 12 weeks after first surgery, which is a continuous variable. The fat-survival rate will be compared between the aPL and the control treatment using a paired t-test with a 0.05 two-sided significance level. A 95% confidence interval for the mean difference will be computed. ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in volume at week 1, week 12 and week 24 after first surgery between left and right breast and comparison pre-operatively to the given time-point and time dependent change in volume breast volume difference after 2 intervention (1 week to 12 week after second intervention) Breast volume at Visit 9 BREASTQ HRQOL SAE, AEs, related to study intervention PRP comparison with historical group to aPL (Comparison of efficacy of aPL enrichment of fat graft versus efficacy of autologous platelet rich plasma (PRP) enrichment of fat graft to the breast (Comparator-historical group from literature search) in literature comparison. Secondary outcome parameters which are measurable at each side will be analysed similarly applying the per-protocol principle.;Timepoint(s) of evaluation of this end point: 1 week, 12 weeks | — |
Countries
Austria
Contacts
Public ContactDani Lutfi
Medical Unversity of Vienna, Department of Gynecology
Outcome results
None listed