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Effect of Autologous Fat Grafting on Acute Burn Wound Healing

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ClinicalTrials.gov Identifier: NCT03791710
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abouzaid, Abouqir General Hospital

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.

Condition or disease Intervention/treatment Phase
Burns Procedure: autologous fat grafting Drug: Topical Cream Procedure: split thickness skin grafting Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Effect of Autologous Fat Grafting and Nanofat Usage on Burn Wound Healing and Early Scarring
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: control group
this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine
Drug: Topical Cream
serial dressing with topical agents e.g Silver Sulphadiazine
Other Name: dressing

Procedure: split thickness skin grafting
depridment and split thickness skin grafting
Other Name: skin grafting

Active Comparator: fat grafting group
this group of patients will have the autologous fat grafting for their burn wounds
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
Other Name: liposuction and lipofilling

Procedure: split thickness skin grafting
depridment and split thickness skin grafting
Other Name: skin grafting




Primary Outcome Measures :
  1. wound healing time [ Time Frame: one to three weeks ]
    the effect of the fat grafting on the wound healing time


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791710


Contacts
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Contact: Ahmed M. Abouzaid, MSc +201224037753 dr_abouzaid@live.com
Contact: Mohamed E Al-Mokadem, MBBCh +201033315474 drsedofa1@gmail.com

Locations
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Egypt
Abouqir General Hospital Recruiting
Alexandria, Egypt, 21527
Contact: Ahmed M Abouzaid, MsC         
Sponsors and Collaborators
Ahmed Mohamed Abouzaid
Investigators
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Principal Investigator: Ahmed M Abouzaid, MSc Abouqir GH

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Responsible Party: Ahmed Mohamed Abouzaid, specialist plastic, reconstructive surgery and burn therapy, Abouqir General Hospital
ClinicalTrials.gov Identifier: NCT03791710    
Other Study ID Numbers: AbouqirBurn1
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Silver Sulfadiazine
Anti-Infective Agents
Anti-Infective Agents, Local