Effect of Autologous Fat Grafting on Acute Burn Wound Healing

Ahmed Mohamed Abouzaid

Status and phase: Completed; Phase 3

Conditions: Burns

Treatments: Procedure: autologous fat grafting; Drug: Topical Cream; Procedure: split thickness skin grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT03791710

AbouqirBurn1

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 13 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine

Treatment:

Procedure: split thickness skin grafting

Drug: Topical Cream

fat grafting group

Active Comparator group

Description:

this group of patients will have the autologous fat grafting for their burn wounds

Treatment:

Procedure: split thickness skin grafting

Procedure: autologous fat grafting