No registrations found.
ID
Source
Brief title
Health condition
Scar formation, scars, wound healing.
Sponsors and support
Intervention
Outcome measures
Primary outcome
POSAS questionnaires, both observer as patient questionnaire.
Secondary outcome
Immunohistological stainings of biopsies.
RNA isolation out of biopsies.
Standardised photographs.
Background summary
In this prospective study we investigate the potential effect of Stromal Vascular Fraction (SVF)
injection as a preventive treatment of scar formation after mamma reduction. All patients will receive
SVF (0,1 ml per 0,5 cm2 scar surface) in 1 scar of 1 breast and 0,9% NaCL (0,1 ml per 0,5 cm2 scar
surface) in the other scar of the breast. Only the lateral side (till 5 cm from the edge) of the horizontal
scar will be treated and investigated in both breasts. SVF will be created by using a mechanical
dissociation procedure named: the FAT (Fractionation of Adipose Tissue) procedure. Postoperative
clinical improvement is measured with the POSAS questionnaire containing the observer scar
assessment and the patient scar assessment and will focus on: vascularization, pigmentation,
thickness, relief, pliability, pain, itchiness, stiffness and irregularity. 1 questionnaire (patient and
observer assessment) is completed for each breast. Postoperative scar improvement is also
measured by RNA isolation and histological observation of biopsies (into the dermal fat layer) on fixed
positions. Histological observation will focus on extracellular matrix remodeling, epidermis renewal,
cell infiltration and new microvasculature formation. RNA isolation will focus on pro- and anti-
inflammatory genes. 1 biopsy is taken of each breast every time. Postoperative improvement is
analyzed by a photographic panel assessment. Photographic evaluation will focus on scar size
reduction, change of color and relief using a Visual Analogue Scale (VAS).1 photograph is taken of
each breast every time. All measurements will be done on predetermined time-points: 6 months and
12 months postoperative, only the biopsies will be taken preoperative as well.
Study objective
Stromal Vascular Fraction injection in the wound edges will prevent scar formation after a mammae reduction compared to a placebo injection.
Study design
Preoperative, 6 months and 12 months postoperative.
Intervention
Stromal Vascular Fraction injection obtained by mechanical dissociation of adipose tissue. 1 ml of Stromal Vascular Fraction will be injected in the lateral 5 cm of the horizontal scar after a mamma reduction.
Boterdiep 94 kamer 23
Groningen 9712 LS
The Netherlands
+31619594029
jorisavandongen@gmail.com
Boterdiep 94 kamer 23
Groningen 9712 LS
The Netherlands
+31619594029
jorisavandongen@gmail.com
Inclusion criteria
• Females
• Age 18-50
• Mamma reduction in both mammae, wise pattern
Exclusion criteria
• Male
• Aged below 18 or above 50 years
• Aged between 18 and 50 and in the menopause or pre-menopause
• 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, 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
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5613 |
| NTR-old | NTR5719 |
| CCMO | NL55651.000.16 |
| OMON | NL-OMON47353 |