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

March 23, 2020 updated by: Katarina Zivec

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI
  • age
  • immunosuppressive disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intradermal injection of stromal vascular fraction
Most lateral 5 cm of abdominal donor site will be injected with stromal vascular fraction just after the wound is closed.
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.
No Intervention: control
Most contralateral 5 cm of abdominal donor site will serve as control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of stromal vascular fraction by flow cytometry
Time Frame: 2 hours
Cell viability and cell type specification of stromal vascular fraction will be evaluated by flow cytometry.
2 hours
Histological analysis of epidermal thickness of scar tissue
Time Frame: 10 months
Epidermal thickens of scar tissue on the injected and control site will be compared.
10 months
Histological analysis of rete ridges of scar tissue
Time Frame: 10 months
Number of rete ridges of scar tissue on the injected and control site will be compared.
10 months
Histological quantification of elastin of scar tissue.
Time Frame: 10 months
Quantification of elastin of scar tissue will be compared on the injected and control site.
10 months
Histological quantification of vascularity in scar tissue
Time Frame: 10 months
Vascularity will be histologically quantified and compared on the injected and control site.
10 months
Histological quantification of inflammatory cells in scar tissue
Time Frame: 10 months
Inflammatory cells will be histologically quantified and compared on the injected and control site.
10 months
Clinical outcome by the use of Patient and Observer Scar Assessment Scale (POSAS)
Time Frame: 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'.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Katarina Zivec

Investigators

  • Principal Investigator: Katarina Zivec, University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

October 10, 2020

Study Registration Dates

First Submitted

January 18, 2020

First Submitted That Met QC Criteria

January 18, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSVF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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