Effect of Autologous Fat Grafting on Acute Burn Wound Healing

NCT ID: NCT03791710

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2020-01-31

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

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

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

Group Type: PLACEBO_COMPARATOR

Topical Cream

Intervention Type: DRUG

serial dressing with topical agents e.g Silver Sulphadiazine

split thickness skin grafting

Intervention Type: PROCEDURE

depridment and split thickness skin grafting

fat grafting group

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

Group Type: ACTIVE_COMPARATOR

autologous fat grafting

Intervention Type: PROCEDURE

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

split thickness skin grafting

Intervention Type: PROCEDURE

depridment and split thickness skin grafting

Interventions

autologous fat grafting

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: PROCEDURE

Topical Cream

serial dressing with topical agents e.g Silver Sulphadiazine

Intervention Type: DRUG

split thickness skin grafting

depridment and split thickness skin grafting

Intervention Type: PROCEDURE

Other Intervention Names

liposuction and lipofilling; dressing; skin grafting

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Mohamed Abouzaid

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abouzaid

specialist plastic, reconstructive surgery and burn therapy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ahmed M Abouzaid, MSc

Role: PRINCIPAL_INVESTIGATOR

Abouqir GH

Locations

Abouqir General Hospital

Alexandria, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 34906386 (View on PubMed)

Other Identifiers

AbouqirBurn1

Identifier Type: -

Identifier Source: org_study_id