ScarsNFWHSFNCT03850119
Nanofat on Wound Healing and Scar Formation
A study testing Nanofat injection in people with Scars and Delayed Wound Healing, run by Universitair Ziekenhuis Brussel.
Trial summary
This study will evaluate the effectiveness and safety of intradermal injection of Nanofat on wound healing and scar formation. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Scars, Delayed Wound Healing, Hypertrophic Scar
- What is being tested?
- Nanofat injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 Mar 2022
- 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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- scheduled for DIEP-flap breast reconstruction surgery at our department
Who cannot join
- smokers
- use of cortisone or other immunsuppressants
- diabetes mellitus type 1 or 2
- age
- connective tissue disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Nanofat on Wound Healing and Scar Formation: a Randomized, Split-scar, Double Blind Trial
This study will evaluate the effectiveness and safety of intradermal injection of Nanofat on wound healing and scar formation.
Read the detailed description
In this monocentric, randomized, controlled, double-blinded prospective interventional study, twenty patients will be included. Each patient will be his/her own control.
Patients undergoing DIEPflap breast reconstruction will be included in this study. During the surgery, the abdominal incision will be divided in two equal sides with the umbilicus as midline reference. The sides will be randomized in a treatment side and control side. The treatment side will receive intradermal nanofat injections after the subcutaneous and right before the intradermal sutures.
The patient and investigators will be blinded for the treatment protocol. The effects on wound healing, adverse events, scar formation and pigmentation will be evaluated up to one year after the surgery.
- Conditions
- Scars, Delayed Wound Healing, Hypertrophic Scar, Post Inflammatory Hyperpigmentation, Donor Site Complication
- Being tested
- Nanofat injection
- Keywords
- adipose derived stem cells, stromal vascular fraction, wound healing, scar formation, donor site morbidity, nanofat
- Medical subject headings
- Cicatrix, Cicatrix, Hypertrophic, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanofat injectionProcedure or surgery
Lipoaspirate, harvested during the surgery, is centrifuged for 1 minute at 2000 rpm to discard infiltration fluid. The residual fat is passed back and forth between two 10cc syringes interlocked with Tulip connecting pieces (2.4, 1.4 and 1.2 diameter, each 10 passes for a total of 30 passes). This is injected intradermally before the intradermal sutures are placed. The donor site is always entirely sutured (both sides) by the same person.
| Study group | Role | What they receive |
|---|---|---|
| Intradermal Nanofat | Experimental | This side of the scar received intradermal injection of nanofat during the closure of the donor site. Receives: Procedure: Nanofat injection |
| Control | No intervention | This side of the scar received no injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale
The abdominal scar will be evaluated clinically by the patient and observer scar assessment scale, starting from one month after the surgery
Measured: one year
Clinical assessment of the time to healing of the abdominal wound
The time for the abdominal wound to heal will be registered. Wound healing is considered a closed and non-dehiscent wound witout signs of inflammation or infection.
Measured: one month
Evaluation of histological parameters on tissue biopsy from both sides of the abdominal scar.
Evaluation of the histological differences of the treatment arm vs. control, by evaluating scar properties on tissue biopsy. Scar thickness, collagen arrangement and angiogenesis will be evaluated.
Measured: six months
Pigmentation Index of the two sides of the scar, measured with a Mexameter
Evaluation of the Pigmentation Index difference in the treatment arm vs. control arm will be measured by the use of a mexameter, starting from one month after the procedure (after wound healing is complete).
Measured: one year
Patient satisfaction of abdominal scar appearance measured by a Visual Analog Scale
Evaluation of patient satisfaction over the entire course of the study by filling in a Visual Analog Scale, with 1 being very unsatisfied and 10 being very satisfied.
Measured: one year
Rate of adverse events
Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarsStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- monocentric randomized controlled double-blinded prospective interventional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustapha Hamdi, Universitair Ziekenhuis Brussel
- Investigators
- Moustapha Hamdi, MD,PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850119
- Sponsor's protocol ID
- 2019-044
- Acronym
- NFWHSF
- Status last verified
- Feb 2019
- First submitted
- 18 Feb 2019
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanofat on Wound Healing and Scar Formation: a Randomized, Split-scar, Double Blind Trial
- ClinicalTrials.gov ID
- NCT03850119
- Acronym / sponsor ID
- NFWHSF / 2019-044
- Conditions
- Scars, Delayed Wound Healing, Hypertrophic Scar, Post Inflammatory Hyperpigmentation, Donor Site Complication
- Keywords
- adipose derived stem cells, stromal vascular fraction, wound healing, scar formation, donor site morbidity, nanofat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 21 Feb 2019 (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.
This study will evaluate the effectiveness and safety of intradermal injection of Nanofat on wound healing and scar formation.
Detailed description
In this monocentric, randomized, controlled, double-blinded prospective interventional study, twenty patients will be included. Each patient will be his/her own control.
Patients undergoing DIEPflap breast reconstruction will be included in this study. During the surgery, the abdominal incision will be divided in two equal sides with the umbilicus as midline reference. The sides will be randomized in a treatment side and control side. The treatment side will receive intradermal nanofat injections after the subcutaneous and right before the intradermal sutures.
The patient and investigators will be blinded for the treatment protocol. The effects on wound healing, adverse events, scar formation and pigmentation will be evaluated up to one year after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- monocentric randomized controlled double-blinded prospective interventional study
| Arm | Type | Receives |
|---|---|---|
| Intradermal Nanofat | Experimental | Procedure: Nanofat injectionThis side of the scar received intradermal injection of nanofat during the closure of the donor site. |
| Control | No intervention | –This side of the scar received no injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for DIEP-flap breast reconstruction surgery at our department
Key exclusion criteria (5 listed)
- smokers
- use of cortisone or other immunsuppressants
- diabetes mellitus type 1 or 2
- age
- connective tissue 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 |
|---|---|---|
| Nanofat injectionLipoaspirate, harvested during the surgery, is centrifuged for 1 minute at 2000 rpm to discard infiltration fluid. The residual fat is passed back and forth between two 10cc syringes interlocked with Tulip connecting pieces (2.4, 1.4 and 1.2 diameter, each 10 passes for a total of 30 passes). This is injected intradermally before the intradermal sutures are placed. The donor site is always entirely sutured (both sides) by the same person. | Procedure or surgery | Intradermal Nanofat |
Primary outcome
Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale
Time frame: one year
The abdominal scar will be evaluated clinically by the patient and observer scar assessment scale, starting from one month after the surgery
Clinical assessment of the time to healing of the abdominal wound
Time frame: one month
The time for the abdominal wound to heal will be registered. Wound healing is considered a closed and non-dehiscent wound witout signs of inflammation or infection.
Evaluation of histological parameters on tissue biopsy from both sides of the abdominal scar.
Time frame: six months
Evaluation of the histological differences of the treatment arm vs. control, by evaluating scar properties on tissue biopsy. Scar thickness, collagen arrangement and angiogenesis will be evaluated.
Pigmentation Index of the two sides of the scar, measured with a Mexameter
Time frame: one year
Evaluation of the Pigmentation Index difference in the treatment arm vs. control arm will be measured by the use of a mexameter, starting from one month after the procedure (after wound healing is complete).
Patient satisfaction of abdominal scar appearance measured by a Visual Analog Scale
Time frame: one year
Evaluation of patient satisfaction over the entire course of the study by filling in a Visual Analog Scale, with 1 being very unsatisfied and 10 being very satisfied.
Rate of adverse events
Time frame: One year
Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- 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.
Moustapha Hamdi, MD,PhD principal investigator
Universitair Ziekenhuis Brussel
Questions about this trial
What is this clinical trial studying?
A study testing Nanofat injection in people with Scars and Delayed Wound Healing, run by Universitair Ziekenhuis Brussel.
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 5 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 21 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moustapha Hamdi, MD, PhD (+ 32 24749400, moustapha.hamdi@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale (time frame: one year). 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 Feb 2019.