Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children

April 18, 2022 updated by: Mohamed Salah El Din Mohamed Hassan, Assiut University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut university faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Mini autogenous skin grafts
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.
Procedure: Mini autogenous skin graft
mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.
ACTIVE_COMPARATOR: Autogenous skin graft
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
Procedure: Mini autogenous skin graft
mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
Time Frame: 2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Mohamed St Salah El Din, Resident, Doctor Mostafa El Sonbaty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (ACTUAL)

October 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assiut

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Plan to do the study then share this study to be useful for all Plastic surgeons all around the world

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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