Wound Heal Clinical Trial
Official title:
Scar Tissue Analysis After Intraoperative Intradermal Application of Stromal Vascular Fraction Cells Into Suture Line
The study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring.
Patients undergoing primary or secondary Deep Inferior Epigastric Perforator (DIEP) flap
breast reconstruction will be included in this monocentric, randomised, controlled,
double-blinded study.
After bilateral flank liposuction, the fat will be processed by a special protocol with
enzymatic digestion. Stromal vascular fraction will be isolated and injected intradermally
just after wound closure into one site of surgical wound (most lateral 5 cm) at the DIEP flap
donor site. The other site of DIEP flap donor site (most lateral 5 cm) will serve as a
control. Part of stromal vascular fraction will be analysed by flow cytometry for the
viability and cell specification. Ten months after DIEP flap surgery the scars at both sites
(control and injected site) will be excised and analysed histologically. At that time
photographs will be taken and scars will be analysed by Patient and Observer Assesment Scale
(POSAS).
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