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

Not Applicable

• Conditions: Scar; Wound Heal; Delayed Wound Healing; Hypertrophic Scar
• Interventions: Procedure: Intradermal stromal vascular fraction injection

• Registration Number: NCT04238468
• Lead Sponsor: Katarina Zivec

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).

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2020-01-18
• Study First Submitted QC: 2020-01-18
• Study First Posted: 2020-01-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-24
• Primary Completion: 2020-04-30
• Study Completion: 2020-10-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction

Exclusion Criteria

• BMI
• age
• immunosuppressive disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradermal injection of stromal vascular fraction	Intradermal stromal vascular fraction injection	Most lateral 5 cm of abdominal donor site will be injected with stromal vascular fraction just after the wound is closed.

Primary Outcome Measures

Name	Time	Method
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'.
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.

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia