Effect of Autologous Fat Grafting on Acute Burn Wound Healing
Primary Purpose
Burns
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
autologous fat grafting
Topical Cream
split thickness skin grafting
Sponsored by
About this trial
This is an interventional treatment trial for Burns
Eligibility Criteria
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.
Sites / Locations
- Abouqir General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
control group
fat grafting group
Arm Description
this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine
this group of patients will have the autologous fat grafting for their burn wounds
Outcomes
Primary Outcome Measures
wound healing time
the effect of the fat grafting on the wound healing time
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03791710
Brief Title
Effect of Autologous Fat Grafting on Acute Burn Wound Healing
Official Title
Effect of Autologous Fat Grafting and Nanofat Usage on Burn Wound Healing and Early Scarring
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Mohamed Abouzaid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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, 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine
Arm Title
fat grafting group
Arm Type
Active Comparator
Arm Description
this group of patients will have the autologous fat grafting for their burn wounds
Intervention Type
Procedure
Intervention Name(s)
autologous fat grafting
Other Intervention Name(s)
liposuction and lipofilling
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Topical Cream
Other Intervention Name(s)
dressing
Intervention Description
serial dressing with topical agents e.g Silver Sulphadiazine
Intervention Type
Procedure
Intervention Name(s)
split thickness skin grafting
Other Intervention Name(s)
skin grafting
Intervention Description
depridment and split thickness skin grafting
Primary Outcome Measure Information:
Title
wound healing time
Description
the effect of the fat grafting on the wound healing time
Time Frame
one to three weeks
Secondary Outcome Measure Information:
Title
effect on pain perception, subjective assessment scale
Description
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.
Time Frame
immediate post-operative and up to three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Abouzaid, MSc
Organizational Affiliation
Abouqir GH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abouqir General Hospital
City
Alexandria
ZIP/Postal Code
21527
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34906386
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Autologous Fat Grafting on Acute Burn Wound Healing
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