Clinical trial NCT04965883: Comparison Between Early Excision and Grafting Versus Dressing and Delayed Grafting in Deep Burn Mangement.
Official title: Comparison Between Early Excision and Grafting Versus Dressing and Delayed Grafting in Deep Burn Mangement.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * All the patients will be included in the study will be resuscitated on arrival in our department.
* Detailed history will be taken and burn evaluation will take place in respect to TBSA according to Lund and Browder chart and burn depth.
* Dreesing will be done with topical antimicrobial agent.
* Fluid resuscitation with lactated Ringer's solution according to modified Parkland's formula.
* Injectable proton pump inhibitors, and analgesics will be started as initial drug therapy.
* Close follow up of the patients will be done then evaluation of the patients will be done in the fourth day and dividing the patients into two groups: the first group "early exicion and grafting " and the second group " dressing and delayed grafting ".
* The first group will include patients with early surgery from 4 to 10 days since burn.
* Dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn.
* Then the data will be collected and analyzed for comparison between the two groups regarding : the timing of operation and its relation to the length of stay, functional outcome and cost of treatment

Detailed description: * The first group will include :

  1. Patients with good general condition and hemodynamically stable that fit for early surgery.
  2. Patients that accept the option of early surgery and can give consent for it .
  3. Patients with available donor site for early grafting.
  4. Patients with burn at certain sites may be of priority for early excision and grafting to avoid long term complication of delayed wound healing such as : on joint surface, hands, feet, and face.
* The early excision will be done surgically within 4-10 days post burn by whatson knife by tangential excision of burned tissue until capillary bleeding appears to make a good bed to be covered with grafts" split thickness grafts STG" at the same time.
* The first dressing will be in the fifth day post operative.
* In the other hand the second group will include:

  1. Patients with bad general condition or hemodynamicaly unstable at the early excision period (4-10 days post burn).
  2. Patients that refuse early surgery and give no consent for early surgery.
  3. Patients with no available donner site for early excision and grafting during the fourth day evaluation .

Eligibility criteria: Inclusion Criteria:

1. Patients who had deep second and third degree burns.
2. patients with flame and scald burns.

Exclusion Criteria:

1. Patients who had only first or superficial second degree burns.
2. patients with high voltage contact electric burns and chemical burns.

Primary outcomes:
measure: Compare the number of blood units needed in both groups ( the first group : early exicion and grafting , the second group : dressing and delayed grafting )
timeFrame: one year
measure: compare the cost of treatment in both groups
timeFrame: one year
Secondary outcomes:
measure: Compare the length of hospital stay between of early excision and grafting(EEG) versus dressing and delayed grafting(DDG) of deep burn.
timeFrame: one year
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Shenouda gamil fayiez
Study officials:
affiliation: Sohag university ,Egypt
name: Mohamed A Elmwalla, MD
role: STUDY_CHAIR
References:
citation: Forjuoh SN. Burns in low- and middle-income countries: a review of available literature on descriptive epidemiology, risk factors, treatment, and prevention. Burns. 2006 Aug;32(5):529-37. doi: 10.1016/j.burns.2006.04.002. Epub 2006 Jun 14.
citation: Khadjibayev AM, Fayazov AD, Djabriyev DA, Kamilov UR. Surgical treatment of deep burns. Ann Burns Fire Disasters. 2008 Sep 30;21(3):150-2.
citation: Janzekovic Z. A new concept in the early excision and immediate grafting of burns. J Trauma. 1970 Dec;10(12):1103-8. No abstract available.