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

Primary Purpose

Wound Heal, Scar, Hypertrophic Scar

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Intradermal stromal vascular fraction injection
Sponsored by
Katarina Zivec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI
  • age
  • immunosuppressive disease

Sites / Locations

  • University Medical Centre Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intradermal injection of stromal vascular fraction

control

Arm Description

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

Most contralateral 5 cm of abdominal donor site will serve as control.

Outcomes

Primary Outcome Measures

Analysis of stromal vascular fraction by flow cytometry
Cell viability and cell type specification of stromal vascular fraction will be evaluated by flow cytometry.
Histological analysis of epidermal thickness of scar tissue
Epidermal thickens of scar tissue on the injected and control site will be compared.
Histological analysis of rete ridges of scar tissue
Number of rete ridges of scar tissue on the injected and control site will be compared.
Histological quantification of elastin of scar tissue.
Quantification of elastin of scar tissue will be compared on the injected and control site.
Histological quantification of vascularity in scar tissue
Vascularity will be histologically quantified and compared on the injected and control site.
Histological quantification of inflammatory cells in scar tissue
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)
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'.

Secondary Outcome Measures

Full Information

First Posted
January 18, 2020
Last Updated
March 23, 2020
Sponsor
Katarina Zivec
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1. Study Identification

Unique Protocol Identification Number
NCT04238468
Brief Title
Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line
Official Title
Scar Tissue Analysis After Intraoperative Intradermal Application of Stromal Vascular Fraction Cells Into Suture Line
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
October 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Katarina Zivec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Scar, Hypertrophic Scar, Delayed Wound Healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intradermal injection of stromal vascular fraction
Arm Type
Experimental
Arm Description
Most lateral 5 cm of abdominal donor site will be injected with stromal vascular fraction just after the wound is closed.
Arm Title
control
Arm Type
No Intervention
Arm Description
Most contralateral 5 cm of abdominal donor site will serve as control.
Intervention Type
Procedure
Intervention Name(s)
Intradermal stromal vascular fraction injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Analysis of stromal vascular fraction by flow cytometry
Description
Cell viability and cell type specification of stromal vascular fraction will be evaluated by flow cytometry.
Time Frame
2 hours
Title
Histological analysis of epidermal thickness of scar tissue
Description
Epidermal thickens of scar tissue on the injected and control site will be compared.
Time Frame
10 months
Title
Histological analysis of rete ridges of scar tissue
Description
Number of rete ridges of scar tissue on the injected and control site will be compared.
Time Frame
10 months
Title
Histological quantification of elastin of scar tissue.
Description
Quantification of elastin of scar tissue will be compared on the injected and control site.
Time Frame
10 months
Title
Histological quantification of vascularity in scar tissue
Description
Vascularity will be histologically quantified and compared on the injected and control site.
Time Frame
10 months
Title
Histological quantification of inflammatory cells in scar tissue
Description
Inflammatory cells will be histologically quantified and compared on the injected and control site.
Time Frame
10 months
Title
Clinical outcome by the use of Patient and Observer Scar Assessment Scale (POSAS)
Description
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'.
Time Frame
10 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction Exclusion Criteria: BMI age immunosuppressive disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarina Zivec
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

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

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