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

Primary Purpose

Burns

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Excision and Grafting
dressing then delayed grafting
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

1 Year - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shenouda gamil fayiez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Excision and Grafting

Dressing and Delayed Grafting

Arm Description

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.

• 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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 .

Full Information

First Posted
June 16, 2021
Last Updated
July 8, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04965883
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2021 (Anticipated)
Primary Completion Date
February 15, 2022 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 : Patients with good general condition and hemodynamically stable that fit for early surgery. Patients that accept the option of early surgery and can give consent for it . Patients with available donor site for early grafting. 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: Patients with bad general condition or hemodynamicaly unstable at the early excision period (4-10 days post burn). Patients that refuse early surgery and give no consent for early surgery. Patients with no available donner site for early excision and grafting during the fourth day evaluation .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Excision and Grafting
Arm Type
Experimental
Arm Description
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.
Arm Title
Dressing and Delayed Grafting
Arm Type
Experimental
Arm Description
• 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.
Intervention Type
Procedure
Intervention Name(s)
Excision and Grafting
Intervention Description
reconstruction of deep burn by grafting
Intervention Type
Procedure
Intervention Name(s)
dressing then delayed grafting
Intervention Description
multiple dressing and delayed grafting
Primary Outcome Measure Information:
Title
Compare the number of blood units needed in both groups ( the first group : early exicion and grafting , the second group : dressing and delayed grafting )
Description
We will estimate how many blood units needed in both groups since admission upto discharge from hospital.
Time Frame
one year
Title
compare the cost of treatment in both groups
Description
regarding how much money will be used since burn upto recovery measured by filling questionnaire by the patients.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Compare the length of hospital stay between of early excision and grafting(EEG) versus dressing and delayed grafting(DDG) of deep burn.
Description
how many days each group will spend in our hospital .
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who had deep second and third degree burns. patients with flame and scald burns. Exclusion Criteria: Patients who had only first or superficial second degree burns. patients with high voltage contact electric burns and chemical burns.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shenouda G Faiez, resident
Phone
01285122834
Email
shenoda011111@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal Y El sayed, MD
Phone
01141669474
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Elmwalla, MD
Organizational Affiliation
Sohag university ,Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Shenouda gamil fayiez
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed A El mawalla, MD
Phone
+20 114 166 9474

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16777340
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.
Results Reference
background
PubMed Identifier
21991128
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.
Results Reference
background
PubMed Identifier
4921723
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.
Results Reference
background

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

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