NCT04238468

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

January 18, 2020

Last Update Submit

March 23, 2020

Conditions

Wound HealScarHypertrophic ScarDelayed Wound Healing

Outcome Measures

Primary Outcomes (7)

  • 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

  • Histological analysis of epidermal thickness of scar tissue

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

    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.

    10 months

  • Histological quantification of elastin of scar tissue.

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

    10 months

  • Histological quantification of vascularity in scar tissue

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

    10 months

  • Histological quantification of inflammatory cells in scar tissue

    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)

    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

Study Arms (2)

Intradermal injection of stromal vascular fraction

EXPERIMENTAL

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

control

NO INTERVENTION

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

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.

Intradermal injection of stromal vascular fraction

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • BMI
  • age
  • immunosuppressive disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

CicatrixCicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katarina Zivec

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2020

First Posted

January 23, 2020

Study Start

April 1, 2018

Primary Completion

April 30, 2020

Study Completion

October 10, 2020

Last Updated

March 24, 2020

Record last verified: 2020-03

Locations

SL(1)