BurnsNCT03312803
Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
A study testing Mini autogenous skin graft in people with Burns, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Burns
- What is being tested?
- Mini autogenous skin graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Patients younger than 3 years old.
- Patients with burns more than 30% of total body surface area.
- Patients with medical or mental diseases.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Burns
- Being tested
- Mini autogenous skin graft
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini autogenous skin graftProcedure or surgery
mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Mini autogenous skin graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start1 Sep 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah El Din Mohamed Hassan, Assiut University
- Investigators
- Mohamed St Salah El Din, Resident, Study chair, Doctor Mostafa El Sonbaty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312803
- Sponsor's protocol ID
- Assiut
- Status last verified
- Apr 2022
- First submitted
- 13 Sep 2017
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to do the study then share this study to be useful for all Plastic surgeons all around the world
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
- ClinicalTrials.gov ID
- NCT03312803
- Acronym / sponsor ID
- Assiut
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini autogenous skin grafts | Active comparator | Procedure: Mini autogenous skin graftwe 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. |
| Autogenous skin graft | Active comparator | Procedure: Mini autogenous skin graftwe 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 |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients younger than 3 years old.
- Patients with burns more than 30% of total body surface area.
- Patients with medical or mental diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini autogenous skin graftmini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children. | Procedure or surgery | Autogenous skin graft, Mini autogenous skin grafts |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: Undecided. Plan to do the study then share this study to be useful for all Plastic surgeons all around the world
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed St Salah El Din, Resident study chair
Doctor Mostafa El Sonbaty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini autogenous skin graft in people with Burns, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.