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Completed

NCT Number: NCT03791710

Effect of Autologous Fat Grafting on Acute Burn Wound Healing

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.

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Key information

Age range

13 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Abouqir General Hospital

Alexandria, 21527, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: liposuction and lipofilling

Topical Cream

Drug

serial dressing with topical agents e.g Silver Sulphadiazine

Other names: dressing

Split thickness skin grafting

Procedure

depridment and split thickness skin grafting

Other names: skin grafting

Primary outcomes

  1. wound healing time

    Time frame: one to three weeks

    the effect of the fat grafting on the wound healing time

Secondary outcomes

  1. effect on pain perception, subjective assessment scale

    Time frame: immediate post-operative and up to three weeks

    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.

Sponsors and collaborators

Lead sponsor

Ahmed Mohamed Abouzaid

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 3, 2019
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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