Burn ScarNCT03627650
Fat Grafting in Skin-grafted Deep Burn Scars
A study testing lipofilling/ fat grafting in people with Burn Scar, run by University Hospital, Ghent.
Trial summary
fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Scar
- What is being tested?
- lipofilling/ fat grafting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 1 Oct 2016
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- early skin-grafted deep burn scars
- otherwise healthy
Who cannot join
- concomitant disease
About this study
Official title: Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial
fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up
Read the detailed description
Objective: A randomised clinical trial was performed to determine the effect of autologous fat grafting on scar formation in early skin-grafted deep burn wounds.
Methods: Included patients received split-thickness skin grafting procedures for deep burn wounds less than 3 months ago. A homogenous scar area in each patient was divided into two equal parts. One part was treated with transcutaneous sharp needle autologous fat grafting, the adjacent part with transcutaneous saline injection as control. Results were evaluated by clinical assessment with scar scale questionnaires, histological examination, and objective scar assessment with Cutometer, Mexameter, Tewameter and Corneometer.
- Conditions
- Burn Scar
- Being tested
- lipofilling/ fat grafting, placebo injection
- Keywords
- burn, scar, fat, grafting
- Medical subject headings
- Burns, Cicatrix, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipofilling/ fat graftingProcedure or surgery
liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous
placebo injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 group of 15 patients | Experimental | procedure/surgery: fat grafting injection of scar Receives: Procedure: lipofilling/ fat grafting |
| Same group of 15 patients | Experimental | procedure/surgery: placebo injection of scar Receives: Procedure: placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of scar quality by histological assessment
histology of scar tissue, scoring by 2 independent blinded anatomopathologists, (numerical scoring of fibroblast activity, collagen and elastin organisation, vascularity) scoring range min 1(close to normal tissue) - 3 (scar characteristics)
Measured: 6 months
improvement of scar quality by physiological testing with cutometer
measures elasticity of the scar; micrometer; higher values better outcome
Measured: 6 months, 1 year
Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale
numerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation
Measured: 1 year
Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale
numerical score 5 to 50: VSS plus surface area; patient assessments of pain, itching, color, stiffness, thickness, relief
Measured: 1 year
improvement of scar quality by physiological testing with TEWA-meter (Trans Epidermal Water Loss-meter)
measures transepidermal water loss; g/m2/h; higher values worse outcome
Measured: 6 months, 1 year
physiological testing of scar tissue by corneometer
measures hydration of the epidermis; corneometer units, higher values better outcome
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 May 2013
- Primary completion10 Sep 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Model description
- randomised controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Blondeel, University Hospital, Ghent
- Investigators
- Maarten AJ Doornaert, MD, Principal investigator, UGent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627650
- Sponsor's protocol ID
- EC 2010/ 572
- Status last verified
- Aug 2018
- First submitted
- 6 Oct 2017
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Grafting in Immature Skin-grafted Burn Scars: a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03627650
- Acronym / sponsor ID
- EC 2010/ 572
- Conditions
- Burn Scar
- Keywords
- burn, scar, fat, grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 10 Sep 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 13 Aug 2018 (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.
fat grafting in human skin-grafted immature burn scars histological, clinical and photographic follow-up
Detailed description
Objective: A randomised clinical trial was performed to determine the effect of autologous fat grafting on scar formation in early skin-grafted deep burn wounds.
Methods: Included patients received split-thickness skin grafting procedures for deep burn wounds less than 3 months ago. A homogenous scar area in each patient was divided into two equal parts. One part was treated with transcutaneous sharp needle autologous fat grafting, the adjacent part with transcutaneous saline injection as control. Results were evaluated by clinical assessment with scar scale questionnaires, histological examination, and objective scar assessment with Cutometer, Mexameter, Tewameter and Corneometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| 1 group of 15 patients | Experimental | Procedure: lipofilling/ fat graftingprocedure/surgery: fat grafting injection of scar |
| Same group of 15 patients | Experimental | Procedure: placebo injectionprocedure/surgery: placebo injection of scar |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- early skin-grafted deep burn scars
- otherwise healthy
Key exclusion criteria (1 listed)
- concomitant 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 |
|---|---|---|
| lipofilling/ fat graftingliposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous | Procedure or surgery | 1 group of 15 patients |
| placebo injection | Procedure or surgery | Same group of 15 patients |
Primary outcome
Improvement of scar quality by histological assessment
Time frame: 6 months
histology of scar tissue, scoring by 2 independent blinded anatomopathologists, (numerical scoring of fibroblast activity, collagen and elastin organisation, vascularity) scoring range min 1(close to normal tissue) - 3 (scar characteristics)
improvement of scar quality by physiological testing with cutometer
Time frame: 6 months, 1 year
measures elasticity of the scar; micrometer; higher values better outcome
Improvement of scar quality by subjective evaluation with numerical Vancouver Scar Scale
Time frame: 1 year
numerical score 0 to 13; ranges vascularity, height/thickness, pliability, and pigmentation
Improvement of scar quality by subjective evaluation with numerical POSAS (Patient and Observer Scar Assessment Scale) Scale
Time frame: 1 year
numerical score 5 to 50: VSS plus surface area; patient assessments of pain, itching, color, stiffness, thickness, relief
improvement of scar quality by physiological testing with TEWA-meter (Trans Epidermal Water Loss-meter)
Time frame: 6 months, 1 year
measures transepidermal water loss; g/m2/h; higher values worse outcome
physiological testing of scar tissue by corneometer
Time frame: 6 months, 1 year
measures hydration of the epidermis; corneometer units, higher values better outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Maarten AJ Doornaert, MD principal investigator
UGent University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing lipofilling/ fat grafting in people with Burn Scar, run by University Hospital, Ghent.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement of scar quality by histological assessment (time frame: 6 months). The study lists 6 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 21 Aug 2018.