Clinical trial NCT03791710: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Burns
Lead sponsor: Abouqir General Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups one will have the fat grafting and the other will be the control group treated with the conventional methods
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: wound healing time
timeFrame: one to three weeks
Secondary outcomes:
measure: effect on pain perception, subjective assessment scale
timeFrame: immediate post-operative and up to three weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Abouqir General Hospital
Study officials:
affiliation: Abouqir GH
name: Ahmed M Abouzaid, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.