BurnsPhase 3NCT03791710
Effect of Autologous Fat Grafting on Acute Burn Wound Healing
A Phase 3 study testing autologous fat grafting, Topical Cream and split thickness skin grafting in people with Burns, run by Ahmed Mohamed Abouzaid at 1 site in Egypt.
Trial summary
the study evaluates the role of autologous fat grafting and the usage of nanofat in the treatment of the acute burn injuries in different genders and its influences on the healing time and hospital stay, pain control, the need and take of a split thickness skin graft and its size, and the end resulting early scarring… Read more about this study
- Who is it for?
- Ages 13 to 60 years
- Conditions the study is for
- Burns
- What is being tested?
- autologous fat grafting, Topical Cream and split thickness skin grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Mar 2019to 31 Jan 2020
- Phase
- Phase 3
- 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 13 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- both males and females within the age frame are candidates.
- previously healthy individuals with no co-morbid conditions e.g cardiac, hepatic, diabetic, vascular or renal disease.
- with TBSA of 10 to 30% affected and of deep dermal to full thickness wound depth, at any part of the body except the genitalia, perineum or the perianal region or those with inhalational injury.
Who cannot join
- other patients aged younger or older than the specified age group.
- patients with co-morbid conditions.
- patients with smaller or larger BSA than the specified BSA.
- burns involving the genitalia, perineum or the perianal region and patients with inhalational injury.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Autologous Fat Grafting and Nanofat Usage on Burn Wound Healing and Early Scarring
the study evaluates the role of autologous fat grafting and the usage of nanofat in the treatment of the acute burn injuries in different genders and its influences on the healing time and hospital stay, pain control, the need and take of a split thickness skin graft and its size, and the end resulting early scarring, in comparison with control group that were treated with traditional methods, so as to find out new method of treating burn injuries and decreasing its morbidity.
Read the detailed description
as the patient is admitted, full evaluation locally ( as regard the wound itself and the areas of fat harvesting) and generally (assessment of the general condition) is done, fluid resuscitation is started as the unit protocol hand in hand with the analgesia and other medications prescribed according to the unit protocol.
the patient's general condition is optimized for surgery of the fat extraction and grafting which typically should be within the first 6 days of admission.
then under anesthesia (any possible type from local and regional up to general anesthesia) liposuction procedure is performed, then fat is processed then grafted at the wound site with other portion prepared as nanofat for topical use and wound coverage, then sterile dressing is applied.
typically follow up is held daily with the dressing change day after another with the use of the nanofat only and sterile dressing
- Conditions
- Burns
- Being tested
- autologous fat grafting, Topical Cream, split thickness skin grafting
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous fat graftingProcedure or surgery
Also called liposuction and lipofilling
regular liposuction procedure at which sufficient amount of fat is extracted from the patient and then the fat is processed then grafted underneath the burn wound
Topical CreamDrug
Also called dressing
serial dressing with topical agents e.g Silver Sulphadiazine
split thickness skin graftingProcedure or surgery
Also called skin grafting
depridment and split thickness skin grafting
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine Receives: Drug: Topical Cream; Procedure: split thickness skin grafting |
| fat grafting group | Active comparator | this group of patients will have the autologous fat grafting for their burn wounds Receives: Procedure: autologous fat grafting; Procedure: split thickness skin grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing time
the effect of the fat grafting on the wound healing time
Measured: one to three weeks
Secondary outcomes (1)
effect on pain perception, subjective assessment scale
effect of the fat grafting on the pain sensation in the burn wound, assessment through a numerical scale starting at "0" indicating no pain at all to "10" the most intense severe pain. the range between "1" and "3" describes mild pain, between "4" and "6" describes moderate pain, and lastly from "7" to "10" severe pain.
Measured: immediate post-operative and up to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start14 Mar 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups one will have the fat grafting and the other will be the control group treated with the conventional methods
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed Abouzaid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mohamed Abouzaid, Abouqir General Hospital
- Investigators
- Ahmed M Abouzaid, MSc, Principal investigator, Abouqir GH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791710
- Sponsor's protocol ID
- AbouqirBurn1
- Status last verified
- Jul 2020
- First submitted
- 27 Dec 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abouzaid AM, El Mokadem ME, Aboubakr AK, Kassem MA, Al Shora AK, Solaiman A. Effect of autologous fat transfer in acute burn wound management: A randomized controlled study. Burns. 2022 Sep;48(6):1368-1385. doi: 10.1016/j.burns.2021.10.011. Epub 2021 Nov 1.
PubMed 34906386
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Fat Grafting and Nanofat Usage on Burn Wound Healing and Early Scarring
- ClinicalTrials.gov ID
- NCT03791710
- Acronym / sponsor ID
- AbouqirBurn1
- Conditions
- Burns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ahmed Mohamed AbouzaidUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 3 Jan 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.
the study evaluates the role of autologous fat grafting and the usage of nanofat in the treatment of the acute burn injuries in different genders and its influences on the healing time and hospital stay, pain control, the need and take of a split thickness skin graft and its size, and the end resulting early scarring, in comparison with control group that were treated with traditional methods, so as to find out new method of treating burn injuries and decreasing its morbidity.
Detailed description
as the patient is admitted, full evaluation locally ( as regard the wound itself and the areas of fat harvesting) and generally (assessment of the general condition) is done, fluid resuscitation is started as the unit protocol hand in hand with the analgesia and other medications prescribed according to the unit protocol.
the patient's general condition is optimized for surgery of the fat extraction and grafting which typically should be within the first 6 days of admission.
then under anesthesia (any possible type from local and regional up to general anesthesia) liposuction procedure is performed, then fat is processed then grafted at the wound site with other portion prepared as nanofat for topical use and wound coverage, then sterile dressing is applied.
typically follow up is held daily with the dressing change day after another with the use of the nanofat only and sterile dressing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups one will have the fat grafting and the other will be the control group treated with the conventional methods
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Topical Cream, Procedure: split thickness skin graftingthis group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine |
| fat grafting group | Active comparator | Procedure: autologous fat grafting, Procedure: split thickness skin graftingthis group of patients will have the autologous fat grafting for their burn wounds |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- both males and females within the age frame are candidates.
- previously healthy individuals with no co-morbid conditions e.g cardiac, hepatic, diabetic, vascular or renal disease.
- with TBSA of 10 to 30% affected and of deep dermal to full thickness wound depth, at any part of the body except the genitalia, perineum or the perianal region or those with inhalational injury.
Key exclusion criteria (4 listed)
- other patients aged younger or older than the specified age group.
- patients with co-morbid conditions.
- patients with smaller or larger BSA than the specified BSA.
- burns involving the genitalia, perineum or the perianal region and patients with inhalational injury.
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 |
|---|---|---|
| autologous fat graftingAlso: liposuction and lipofillingregular liposuction procedure at which sufficient amount of fat is extracted from the patient and then the fat is processed then grafted underneath the burn wound | Procedure or surgery | fat grafting group |
| Topical CreamAlso: dressingserial dressing with topical agents e.g Silver Sulphadiazine | Drug | control group |
| split thickness skin graftingAlso: skin graftingdepridment and split thickness skin grafting | Procedure or surgery | control group, fat grafting group |
Primary outcome
wound healing time
Time frame: one to three weeks
the effect of the fat grafting on the wound healing time
1 secondary outcome
effect on pain perception, subjective assessment scale
Time frame: immediate post-operative and up to three weeks
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 10 Jul 2020.
- Derived from this study: PubMed 34906386Abouzaid AM, El Mokadem ME, Aboubakr AK, Kassem MA, Al Shora AK, Solaiman A. Effect of autologous fat transfer in acute burn wound management: A randomized controlled study. Burns. 2022 Sep;48(6):1368-1385. doi: 10.1016/j.burns.2021.10.011. Epub 2021 Nov 1.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed M Abouzaid, MSc principal investigator
Abouqir GH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing autologous fat grafting, Topical Cream and split thickness skin grafting in people with Burns, run by Ahmed Mohamed Abouzaid at 1 site in Egypt.
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 3 inclusion and 4 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 10 Jul 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
wound healing time (time frame: one to three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03791710, which also lists 1 linked publication.
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 10 Jul 2020.