Effect of Autologous Fat Grafting on Acute Burn Wound Healing

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Burns

Intervention / Treatment
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* Procedure: autologous fat grafting
* Drug: Topical Cream
* Procedure: split thickness skin grafting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups one will have the fat grafting and the other will be the control group treated with the conventional methods
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine | Drug: Topical Cream<br>* serial dressing with topical agents e.g Silver Sulphadiazine<br>* Other names: dressing;Procedure: split thickness skin grafting<br>* depridment and split thickness skin grafting<br>* Other names: skin grafting;|
| Active Comparator: fat grafting group<br>this group of patients will have the autologous fat grafting for their burn wounds | Procedure: autologous fat grafting<br>* 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<br>* Other names: liposuction and lipofilling;Procedure: split thickness skin grafting<br>* depridment and split thickness skin grafting<br>* Other names: skin grafting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing time | the effect of the fat grafting on the wound healing time | one to three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |