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

NCT04965883 | Unknown

• 1 other identifier: Soh-Med-21-06-08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Burns

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Compare the length of hospital stay between of early excision and grafting(EEG) versus dressing and delayed grafting(DDG) of deep burn.

  one year

Study Arms (2)

Early Excision and Grafting

EXPERIMENTAL

* 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

Dressing and Delayed Grafting

EXPERIMENTAL

• 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

Interventions

Excision and Grafting PROCEDURE

reconstruction of deep burn by grafting

Early Excision and Grafting

dressing then delayed grafting PROCEDURE

multiple dressing and delayed grafting

Dressing and Delayed Grafting

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Shenouda gamil fayiez

Sohag, Egypt

Location

Related 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. doi: 10.1016/j.burns.2006.04.002. Epub 2006 Jun 14.

  PMID: 16777340 BACKGROUND

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

  PMID: 21991128 BACKGROUND

• 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.

  PMID: 4921723 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Mohamed A Elmwalla, MD

  Sohag university ,Egypt

  STUDY CHAIR

Central Study Contacts

shenouda G Faiez, resident

CONTACT

01285122834; shenoda011111@med.sohag.edu.eg

Gamal Y El sayed, MD

CONTACT

01141669474

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at plastic surgery department sohag university hospital

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 16, 2021
• Study Start: July 30, 2021
• Primary Completion: February 15, 2022
• Study Completion: March 15, 2022
• Last Updated: July 16, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)