Comparison Between Early Excision and Grafting Versus Dressing and Delayed Grafting in Deep Burn Mangement.

• 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

Study Overview

• Status: Not yet recruiting
• Conditions: Burns
• Intervention / Treatment: Procedure: Excision and Grafting; Procedure: dressing then delayed grafting

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: shenouda G Faiez, resident; Phone Number: 01285122834; Email: shenoda011111@med.sohag.edu.eg
• Study Contact Backup: Name: Gamal Y El sayed, MD; Phone Number: 01141669474

Study Locations

• Egypt
  • Sohag, Egypt
    • Shenouda gamil fayiez
    • Contact: Mohamed A El mawalla, MD; Phone Number: +20 114 166 9474

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Excision and Grafting; 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.	Procedure: Excision and Grafting; reconstruction of deep burn by grafting
Experimental: Dressing and Delayed Grafting; • 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.	Procedure: dressing then delayed grafting; multiple dressing and delayed grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the number of blood units needed in both groups ( the first group : early exicion and grafting , the second group : dressing and delayed grafting )	We will estimate how many blood units needed in both groups since admission upto discharge from hospital.	one year
compare the cost of treatment in both groups	regarding how much money will be used since burn upto recovery measured by filling questionnaire by the patients.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the length of hospital stay between of early excision and grafting(EEG) versus dressing and delayed grafting(DDG) of deep burn.	how many days each group will spend in our hospital .	one year

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Chair: Mohamed A Elmwalla, MD, Sohag university ,Egypt

Publications and helpful links

General Publications

• 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.
• Khadjibayev AM, Fayazov AD, Djabriyev DA, Kamilov UR. Surgical treatment of deep burns. Ann Burns Fire Disasters. 2008 Sep 30;21(3):150-2.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 30, 2021
• Primary Completion (Anticipated): February 15, 2022
• Study Completion (Anticipated): March 15, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: Soh-Med-21-06-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No