Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:11 PM
Study NCT ID:
NCT04238468
Status:
UNKNOWN
Last Update Posted:
2020-03-24
First Post:
2020-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line
Sponsor:
Katarina Zivec
Organization:
Study Overview
Official Title:
Scar Tissue Analysis After Intraoperative Intradermal Application of Stromal Vascular Fraction Cells Into Suture Line
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: