Wound HealNCT04238468
Scar Tissue Analysis After Intraoperative Application of Stromal Vascular Fraction Cells Into Suture Line
A study testing Intradermal stromal vascular fraction injection in people with Wound Heal and Scar, run by Katarina Zivec at 1 site in Slovenia.
Trial summary
The study will evaluate the effect of intradermal injection of stromal vascular fraction into suture line on wound healing and scarring. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Scar, Hypertrophic Scar
- What is being tested?
- Intradermal stromal vascular fraction injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Apr 2018to 10 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction
Who cannot join
- BMI
- age
- immunosuppressive disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Wound Heal, Scar, Hypertrophic Scar, Delayed Wound Healing
- Being tested
- Intradermal stromal vascular fraction injection
- Medical subject headings
- Cicatrix, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal stromal vascular fraction injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intradermal stromal vascular fraction injection |
| control | No intervention | Most contralateral 5 cm of abdominal donor site will serve as control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of stromal vascular fraction by flow cytometry
Cell viability and cell type specification of stromal vascular fraction will be evaluated by flow cytometry.
Measured: 2 hours
Histological analysis of epidermal thickness of scar tissue
Epidermal thickens of scar tissue on the injected and control site will be compared.
Measured: 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.
Measured: 10 months
Histological quantification of elastin of scar tissue.
Quantification of elastin of scar tissue will be compared on the injected and control site.
Measured: 10 months
Histological quantification of vascularity in scar tissue
Vascularity will be histologically quantified and compared on the injected and control site.
Measured: 10 months
Histological quantification of inflammatory cells in scar tissue
Inflammatory cells will be histologically quantified and compared on the injected and control site.
Measured: 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'.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Apr 2018
- Primary completion30 Apr 2020 (estimated)
- Study completion10 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katarina Zivec
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Katarina Zivec, University Medical Centre Ljubljana
- Investigators
- Katarina Zivec, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238468
- Sponsor's protocol ID
- SSVF
- Status last verified
- Mar 2020
- First submitted
- 18 Jan 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scar Tissue Analysis After Intraoperative Intradermal Application of Stromal Vascular Fraction Cells Into Suture Line
- ClinicalTrials.gov ID
- NCT04238468
- Acronym / sponsor ID
- SSVF
- Conditions
- Wound Heal, Scar, Hypertrophic Scar, Delayed Wound Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Katarina ZivecUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 10 Oct 2020 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradermal injection of stromal vascular fraction | Experimental | Procedure: Intradermal stromal vascular fraction injectionMost lateral 5 cm of abdominal donor site will be injected with stromal vascular fraction just after the wound is closed. |
| control | No intervention | –Most contralateral 5 cm of abdominal donor site will serve as control. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- breast cancer patients scheduled for primary or secondary DIEP flap breast reconstruction
Key exclusion criteria (3 listed)
- BMI
- age
- immunosuppressive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradermal stromal vascular fraction injectionAfter 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. | Procedure or surgery | Intradermal injection of stromal vascular fraction |
Primary outcome
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.
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.
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.
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.
Histological quantification of vascularity in scar tissue
Time frame: 10 months
Vascularity will be histologically quantified and compared on the injected and control site.
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.
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'.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
Related trials for Wound Heal
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
Functional Hypothalamic Amenorrhea
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarina Zivec principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal stromal vascular fraction injection in people with Wound Heal and Scar, run by Katarina Zivec at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of stromal vascular fraction by flow cytometry (time frame: 2 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.