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van CCT (UK)

van CCT (UK)

Stromal Vascular Fraction injectable as a preventive treatment of scars.

- candidate number24251
- NTR NumberNTR5719
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-apr-2016
- Secondary IDsNL55651.000.16 
- Public TitleStromal Vascular Fraction injectable as a preventive treatment of scars.
- Scientific TitleStromal Vascular Fraction injectable as a preventive treatment of scars.
- ACRONYMPOSAS Trial (Prevention of Scars with Adipose Stroma)
- hypothesisStromal Vascular Fraction injection in the wound edges will prevent scar formation after a mammae reduction compared to a placebo injection.
- Healt Condition(s) or Problem(s) studiedScar
- 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
Pregnancy or active child wish
Frequent exposure to known carcinogenic substances (e.g. work related).
Active or previous use of hormone replacement therapy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate1-mei-2018
- Target number of participants38
- InterventionsStromal 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.
- Primary outcomePOSAS questionnaires, both observer as patient questionnaire.
- Secondary outcomeImmunohistological stainings of biopsies.
RNA isolation out of biopsies.
Standardised photographs.
- TimepointsPreoperative, 6 months and 12 months postoperative.
- Trial web site-
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD18-apr-2016 - 2-mei-2016

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