Effect of Autologous Fat Grafting on Acute Burn Wound Healing

Burns Clinical Trial

Official title:

Effect of Autologous Fat Grafting and Nanofat Usage on Burn Wound Healing and Early Scarring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791710
• Other study ID #: AbouqirBurn1
• Status: Completed
• Phase: Phase 3
• Start date: March 14, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2020
• Source: Abouqir General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Procedure:
• 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

Drug:
• Topical Cream
serial dressing with topical agents e.g Silver Sulphadiazine

Procedure:
• split thickness skin grafting
depridment and split thickness skin grafting

Locations

Country	Name	City	State
Egypt	Abouqir General Hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Mohamed Abouzaid

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing time	the effect of the fat grafting on the wound healing time	one to three weeks
Secondary	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.	immediate post-operative and up to three weeks