Effect of Autologous Fat Grafting on Acute Burn Wound Healing

NCT03791710 | Completed Phase 3

• 1 other identifier: AbouqirBurn1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• wound healing time

  the effect of the fat grafting on the wound healing time

  one to three weeks

Secondary Outcomes (1)

• effect on pain perception, subjective assessment scale

  immediate post-operative and up to three weeks

Study Arms (2)

control group

PLACEBO COMPARATOR

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

Drug: Topical Cream; Procedure: split thickness skin grafting

fat grafting group

ACTIVE COMPARATOR

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

Procedure: autologous fat grafting; Procedure: split thickness skin grafting

Interventions

autologous fat grafting 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

Also known as: liposuction and lipofilling

fat grafting group

Topical Cream DRUG

serial dressing with topical agents e.g Silver Sulphadiazine

Also known as: dressing

control group

split thickness skin grafting PROCEDURE

depridment and split thickness skin grafting

Also known as: skin grafting

control group; fat grafting group

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahmed Mohamed Abouzaid: lead

Study Sites (1)

Abouqir General Hospital

Alexandria, 21527, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34906386 DERIVED

MeSH Terms

Conditions

Burns

Interventions

Lipectomy; Floderm topical cream; Bandages; Skin Transplantation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures; Equipment and Supplies; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Dermatologic Surgical Procedures; Transplantation

Study Officials

• Ahmed M Abouzaid, MSc

  Abouqir GH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: specialist plastic, reconstructive surgery and burn therapy

Model Details: two groups one will have the fat grafting and the other will be the control group treated with the conventional methods

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 3, 2019
• Study Start: March 14, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

EG (1)