Effect of Autologous Fat Grafting on Acute Burn Wound Healing

Sponsor
Ahmed Mohamed Abouzaid (Other)
Overall Status
Completed
CT.gov ID
NCT03791710
Collaborator
(none)
100
1
2
10.6
9.4

Study Details

Study Description

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
  • 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

Study Design

Study Type:
Interventional
Actual Enrollment :
100 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 methodstwo 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 :
Mar 14, 2019
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

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 Names:
  • dressing
  • Procedure: split thickness skin grafting
    depridment and split thickness skin grafting
    Other Names:
  • 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 Names:
  • liposuction and lipofilling
  • Procedure: split thickness skin grafting
    depridment and split thickness skin grafting
    Other Names:
  • skin grafting
  • Outcome Measures

    Primary Outcome Measures

    1. wound healing time [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abouqir General Hospital Alexandria Egypt 21527

    Sponsors and Collaborators

    • Ahmed Mohamed Abouzaid

    Investigators

    • Principal Investigator: Ahmed M Abouzaid, MSc, Abouqir GH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jan 3, 2019
    Last Update Posted:
    Jul 10, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 10, 2020