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

NCT ID: NCT04965883

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2022-03-15

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 .

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Excision and Grafting

Intervention Type: PROCEDURE

reconstruction of deep burn by grafting

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.

Group Type: EXPERIMENTAL

dressing then delayed grafting

Intervention Type: PROCEDURE

multiple dressing and delayed grafting

Interventions

Excision and Grafting

reconstruction of deep burn by grafting

Intervention Type: PROCEDURE

dressing then delayed grafting

multiple dressing and delayed grafting

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Shenoda Gamel Fayez

resident doctor at plastic surgery department sohag university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed A Elmwalla, MD

Role: STUDY_CHAIR

Sohag university ,Egypt

Locations

Shenouda gamil fayiez

Sohag, , Egypt

Countries

Egypt

Central Contacts

shenouda G Faiez, resident

Role: CONTACT

shenoda011111@med.sohag.edu.eg

01285122834

Gamal Y El sayed, MD

Role: CONTACT

01141669474

Facility Contacts

Mohamed A El mawalla, MD

Role: primary

+20 114 166 9474

References

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.

Reference Type: BACKGROUND

PMID: 16777340 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 21991128 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 4921723 (View on PubMed)

Other Identifiers

Soh-Med-21-06-08

Identifier Type: -

Identifier Source: org_study_id