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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04238468
• Other study ID #: SSVF
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: October 10, 2020

Study information

• Verified date: March 2020
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: October 10, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• BMI

• age

• immunosuppressive disease

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Delayed Wound Healing
• Hypertrophic Scar
• Scar
• Wound Heal
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Katarina Zivec

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of stromal vascular fraction by flow cytometry	Cell viability and cell type specification of stromal vascular fraction will be evaluated by flow cytometry.	2 hours
Primary	Histological analysis of epidermal thickness of scar tissue	Epidermal thickens of scar tissue on the injected and control site will be compared.	10 months
Primary	Histological analysis of rete ridges of scar tissue	Number of rete ridges of scar tissue on the injected and control site will be compared.	10 months
Primary	Histological quantification of elastin of scar tissue.	Quantification of elastin of scar tissue will be compared on the injected and control site.	10 months
Primary	Histological quantification of vascularity in scar tissue	Vascularity will be histologically quantified and compared on the injected and control site.	10 months
Primary	Histological quantification of inflammatory cells in scar tissue	Inflammatory cells will be histologically quantified and compared on the injected and control site.	10 months
Primary	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'.	10 months