Trials / Unknown
UnknownNCT04238468
Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line
Scar Tissue Analysis After Intraoperative Intradermal Application of Stromal Vascular Fraction Cells Into Suture Line
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Katarina Zivec · Academic / Other
- Sex
- Female
- Age
- 20 Years – 65 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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. |
Timeline
- Start date
- 2018-04-01
- Primary completion
- 2020-04-30
- Completion
- 2020-10-10
- First posted
- 2020-01-23
- Last updated
- 2020-03-24
Locations
1 site across 1 country: Slovenia
Source: ClinicalTrials.gov record NCT04238468. Inclusion in this directory is not an endorsement.