Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line

Katarina Zivec20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Wound Heal Scar Hypertrophic Scar Delayed Wound Healing

Interventions

Intradermal stromal vascular fraction injectionPROCEDURE

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

Sex: FEMALEMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction Exclusion Criteria: * BMI * age * immunosuppressive disease

Locations (1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

Analysis of stromal vascular fraction by flow cytometry

Cell viability and cell type specification of stromal vascular fraction will be evaluated by flow cytometry.

Time frame: 2 hours

Histological analysis of epidermal thickness of scar tissue

Epidermal thickens of scar tissue on the injected and control site will be compared.

Time frame: 10 months

Histological analysis of rete ridges of scar tissue

Number of rete ridges of scar tissue on the injected and control site will be compared.

Time frame: 10 months

Histological quantification of elastin of scar tissue.

Quantification of elastin of scar tissue will be compared on the injected and control site.

Time frame: 10 months

Histological quantification of vascularity in scar tissue

Vascularity will be histologically quantified and compared on the injected and control site.

Time frame: 10 months

Histological quantification of inflammatory cells in scar tissue

Inflammatory cells will be histologically quantified and compared on the injected and control site.

Time frame: 10 months

Clinical outcome by the use of Patient and Observer Scar Assessment Scale (POSAS)

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'.

Data from ClinicalTrials.gov

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