Delayed Wound Healing, Hypertrophic Scar, Scar, Wound Heal
Conditions
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).
Interventions
PROCEDUREIntradermal 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.
Sponsors
Katarina Zivec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patient, investigator, outcome assessor will be blinded for which side of the scar was injected with stromal vascular fraction. Only the surgeon will know which site was injected.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction
Exclusion criteria
* BMI * age * immunosuppressive disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of stromal vascular fraction by flow cytometry | 2 hours | Cell viability and cell type specification of stromal vascular fraction will be evaluated by flow cytometry. |
| Histological analysis of epidermal thickness of scar tissue | 10 months | Epidermal thickens of scar tissue on the injected and control site will be compared. |
| Histological analysis of rete ridges of scar tissue | 10 months | Number of rete ridges of scar tissue on the injected and control site will be compared. |
| Histological quantification of elastin of scar tissue. | 10 months | Quantification of elastin of scar tissue will be compared on the injected and control site. |
| Histological quantification of vascularity in scar tissue | 10 months | Vascularity will be histologically quantified and compared on the injected and control site. |
| Histological quantification of inflammatory cells in scar tissue | 10 months | Inflammatory cells will be histologically quantified and compared on the injected and control site. |
| Clinical outcome by the use of Patient and Observer Scar Assessment Scale (POSAS) | 10 months | Scar will be evaluated by the Patient and Observer Scar Assessment Scale. The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically and make up a 'Total Score' of the Patient and Observer Scale. The sum altogether will give the 'Total Score' of the POSAS. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of colour). Moreover, the patient and observer also score their 'Overall Opinion'. |
Countries
Slovenia
Outcome results
None listed