Effect of Autologous Fat Grafting on Acute Burn Wound Healing
July 9, 2020 updated by: Ahmed Mohamed Abouzaid
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alexandria, Egypt, 21527
- Abouqir General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 56 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: control group
this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine
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serial dressing with topical agents e.g Silver Sulphadiazine
Other Names:
depridment and split thickness skin grafting
Other Names:
|
|
Active Comparator: fat grafting group
this group of patients will have the autologous fat grafting for their burn wounds
|
depridment and split thickness skin grafting
Other Names:
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
wound healing time
Time Frame: one to three weeks
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the effect of the fat grafting on the wound healing time
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one to three weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
effect on pain perception, subjective assessment scale
Time Frame: immediate post-operative and up to three weeks
|
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.
|
immediate post-operative and up to three weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed M Abouzaid, MSc, Abouqir GH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 14, 2019
Primary Completion (Actual)
January 31, 2020
Study Completion (Actual)
January 31, 2020
Study Registration Dates
First Submitted
December 27, 2018
First Submitted That Met QC Criteria
December 28, 2018
First Posted (Actual)
January 3, 2019
Study Record Updates
Last Update Posted (Actual)
July 10, 2020
Last Update Submitted That Met QC Criteria
July 9, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AbouqirBurn1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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