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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04965883
• Other study ID #: Soh-Med-21-06-08
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: July 2021
• Source: Sohag University
• Contact: shenouda G Faiez, resident
• Phone: 01285122834
• Email: shenoda011111[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Procedure:
• Excision and Grafting
reconstruction of deep burn by grafting
• dressing then delayed grafting
multiple dressing and delayed grafting

Locations

Country	Name	City	State
Egypt	Shenouda gamil fayiez	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Epub 2006 Jun 14. Review. — View Citation

Janzekovic Z. A new concept in the early excision and immediate grafting of burns. J Trauma. 1970 Dec;10(12):1103-8. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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