Hypertrophic skin mammareduction prevention of scars
Conditions
Interventions
All patients will receive SVF (0,1 ml per 0,1 cm2 scar surface) in 1 scar of 1
breast (Side A) and 0,9% NaCL (0,1 ml per 0,1 cm2 scar surface) in the other
scar of the breast (Side B). Only the late
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Females - Aged 18-60 - Mamma reduction in both mammae, wise pattern
Exclusion criteria
Exclusion criteria: - Male - Aged below 18 or above 60 years - Surgical interventions of the breasts in the year prior to the date of surgery - Mammareduction of 1 mamma - 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) - Smoking - Prednisone or other immunotherapy - 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 patient part of the POSAS questionnaire and will focus on: vascularization, pigmentation, thickness, relief, pliability, pain, itchiness, stiffness and irregularity. Questionnaires will be given at predetermined time-points (6 months and 1 year postoperative). 1 questionnaire is completed for each breast every time. The sample size calculation is based on the patient scar assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative clinical improvement is measured with the observer part of the POSAS questionnaire and will focus on: vascularization, pigmentation, thickness, relief, pliability, pain, itchiness, stiffness and irregularity. Questionnaires will be given at predetermined time-points (6 months and 1 year postoperative). 1 questionnaire is completed for each breast every time. The sample size calculation is based on the patient scar assessment. Postoperative scar improvement is measured by histological observation of biopsies (into the dermal fat layer) on fixed positions at predetermined time-points (preoperative, 6 months and 1 year postoperative. Histological observation will focus on extracellular matrix remodelling, epidermis renewal, cell infiltration and new microvasculature formation. 1 biopsy is taken 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 (preoperative, 6 months and 1 year postoperative). 1 photograph is taken of each breast every time. | — |
Countries
Netherlands
Outcome results
None listed