Back to resultsMini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
Primary Purpose
Burns
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mini autogenous skin graft
Sponsored by
About this trial
This is an interventional treatment trial for Burns
Eligibility Criteria
Inclusion Criteria:
- This study will include children (3-12) years old with (10-30) % body surface area burns, admitted to Assuit university hospital burn unit.
- The raw areas in both upper and lower limbs will be the site of the study.
Exclusion Criteria:
- Patients younger than 3 years old.
- Patients with burns more than 30% of total body surface area.
- Patients with medical or mental diseases.
Sites / Locations
- Assiut University Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mini autogenous skin grafts
Autogenous skin graft
Arm Description
we take the autogenous skin graft from the same patient then cut it into small pieces then we spread it over the burn wound on one limb then cover these small pieces with homogenous skin graft taken from another person.
we take the regular autogenous one piece skin graft from the same patient and cover the burn wound on the other limb then we make a comparison between both limbs
Outcomes
Primary Outcome Measures
The major outcome is to specify if the regular single piece autogenous skin graft is better than the new technique that uses small pieces mini autogenous skin grafts for treatment of post burn wounds in children. or vice versa?
the spread of the small pieced autogenous skin grafts that are covered with homogenous skin graft over post burn wounds in children may give better results than the regular single pieced autogenous skin graft
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03312803
Brief Title
Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
Official Title
Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective study comparing the use of mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.
Detailed Description
A prospective study comparing the use of mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children so that the patient can continue on his/her normal life early with less deformities
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
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mini autogenous skin grafts
Arm Type
Active Comparator
Arm Description
we take the autogenous skin graft from the same patient then cut it into small pieces then we spread it over the burn wound on one limb then cover these small pieces with homogenous skin graft taken from another person.
Arm Title
Autogenous skin graft
Arm Type
Active Comparator
Arm Description
we take the regular autogenous one piece skin graft from the same patient and cover the burn wound on the other limb then we make a comparison between both limbs
Intervention Type
Procedure
Intervention Name(s)
Mini autogenous skin graft
Intervention Description
mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.
Primary Outcome Measure Information:
Title
The major outcome is to specify if the regular single piece autogenous skin graft is better than the new technique that uses small pieces mini autogenous skin grafts for treatment of post burn wounds in children. or vice versa?
Description
the spread of the small pieced autogenous skin grafts that are covered with homogenous skin graft over post burn wounds in children may give better results than the regular single pieced autogenous skin graft
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
This study will include children (3-12) years old with (10-30) % body surface area burns, admitted to Assuit university hospital burn unit.
The raw areas in both upper and lower limbs will be the site of the study.
Exclusion Criteria:
Patients younger than 3 years old.
Patients with burns more than 30% of total body surface area.
Patients with medical or mental diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed St Salah El Din, Resident
Organizational Affiliation
Doctor Mostafa El Sonbaty
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut University Faculty of medicine
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Plan to do the study then share this study to be useful for all Plastic surgeons all around the world
Learn more about this trial
Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
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