Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line
NCT ID: NCT04238468
Last Updated: 2020-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-04-01
2020-10-10
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intradermal injection of stromal vascular fraction
Most lateral 5 cm of abdominal donor site will be injected with stromal vascular fraction just after the wound is closed.
Intradermal stromal vascular fraction injection
After flank liposuction, lipoaspirate will be processed by enzymatic digestion, thus stromal vascular fraction will be isolated. Just after the wound is closed the stromal vascular fraction diluted in normal saline (5ml) will be injected intradermally on one site.
control
Most contralateral 5 cm of abdominal donor site will serve as control.
No interventions assigned to this group
Interventions
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Intradermal stromal vascular fraction injection
After flank liposuction, lipoaspirate will be processed by enzymatic digestion, thus stromal vascular fraction will be isolated. Just after the wound is closed the stromal vascular fraction diluted in normal saline (5ml) will be injected intradermally on one site.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* age
* immunosuppressive disease
20 Years
65 Years
FEMALE
Yes
Sponsors
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Katarina Zivec
OTHER
Responsible Party
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Katarina Zivec
Principal Investigator
Principal Investigators
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Katarina Zivec
Role: PRINCIPAL_INVESTIGATOR
University Medical Centre Ljubljana
Locations
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University Medical Centre Ljubljana
Ljubljana, , Slovenia
Countries
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Other Identifiers
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SSVF
Identifier Type: -
Identifier Source: org_study_id
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