NCT03312803

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

2.5 years

First QC Date

September 13, 2017

Last Update Submit

April 18, 2022

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Study Arms (2)

Mini autogenous skin grafts

ACTIVE COMPARATOR

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

Autogenous skin graft

ACTIVE COMPARATOR

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

Interventions

Mini autogenous skin graftPROCEDURE

mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.

Autogenous skin graftMini autogenous skin grafts

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients younger than 3 years old.
  • Patients with burns more than 30% of total body surface area.
  • Patients with medical or mental diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Faculty of medicine

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Mohamed St Salah El Din, Resident

    Doctor Mostafa El Sonbaty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 13, 2017

First Posted

October 18, 2017

Study Start

September 1, 2017

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

EG(1)