mamma reduction tissue healing
Conditions
Interventions
All patients will randomly receive all treatments in one part of four
predesigned equal parts of the two caudal scars of the mamma reduction wise
pattern. Two equal parts per breast: 1) SVF + PRP (0
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Females Age 18-60 BMI equal to or below 30 Patients undergoing a mamma reduction
Exclusion criteria
Exclusion criteria: Male Aged below 18 or above 60 years Aged between 18 and 60 and in the menopause or pre-menopause BMI above 30 Surgical interventions of the mammae in the year prior to the date of surgery Any oncological event in the patients* history A known psychiatric condition A known systemic disease that will impair wound healing (e.g. diabetes mellitus, known atherosclerosis with an event that required hospitalization, collagen diseases, diseases of the skin, HIV). Prednisone or other immunotherapy Smoking Pregnancy or active child wish Frequent exposure to known carcinogenic substances (e.g. work related). Active or previous use of hormone replacement therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative clinical improvement is measured with the POSAS questionnaire containing the patient scar assessment and will focus on: vascularization, pigmentation, thickness, relief, pliability, pain, itchiness, stiffness and irregularity. Questionnaires will be given at predetermined time-points (2 weeks, 6 weeks, 12 weeks and 52 weeks postoperative). One questionnaire per patient is completed for each part of the scar of each breast every time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative clinical improvement is measured with the POSAS questionnaire containing the observer scar assessment and will focus on: vascularization, pigmentation, thickness, relief, pliability, pain, itchiness, stiffness and irregularity. Questionnaires will be given at predetermined time-points (2 weeks, 6 weeks, 12 weeks and 52 weeks postoperative). One questionnaire is completed for each part of the scar of each breast every time. Postoperative scar improvement is measured by histological observation of biopsies (into the dermal fat layer) at predetermined time-points (6 weeks and 12 weeks). Histological observation will focus on extracellular matrix remodelling, epidermis renewal, cell infiltration and new microvasculature formation. One biopsy is taken of each part of the scar of each breast every time. Postoperative improvement analysed by a photographic panel assessment. Photographic evaluation will focus on scar size reduction, change of colour and relief using a Visual Analogue Scale (VAS). Standardized photos will be taken at predetermined time-points (2 weeks, 6 weeks, 12 weeks and 52 weeks). One photograph is taken of the scar of each breast every time. | — |
Countries
Netherlands
Outcome results
None listed