Tilapia Fish Skin in Burn CoverageTFSNCT06549569
Burn Coverage of Burn by Tilapia Fish Skin
An observational study of Tilapia Fish Skin in Burn Coverage, run by Aswan University at 1 site in Egypt.
Trial summary
The goal of this experimental study is to compare TFS and regular dressings as coverage for acute thermal burns. The main question it aims to answer is: Is TFS effective in treating thermal burns? burn induction was done on rabbits to obtain second-degree thermal burn, followed by coverage with TFS Read more about this study
- Who is it for?
- Ages 1 year to 18 months, men only
- Conditions the study is for
- Tilapia Fish Skin in Burn Coverage
- What is being tested?
- TFS
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Aug 2024
- Phase
- Observational
- 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 1 year to 18 months
- Men only
- No healthy volunteers
- Child
Study population: animal rabbits
Who may be able to join
- healthy male one year old rabbit
Who cannot join
- female unhealthy rabbits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tilapia Fish Skin Coverage in Acute Thermal Burn; Experimental and Histopathological Study
The goal of this experimental study is to compare TFS and regular dressings as coverage for acute thermal burns. The main question it aims to answer is:
Is TFS effective in treating thermal burns? burn induction was done on rabbits to obtain second-degree thermal burn, followed by coverage with TFS
Read the detailed description
Nile Tilapia Fish Skin (NTFS) has been suggested as an option for biological material for the management of burns. Nile Tilapia Fish Skin also presented a large composition of type I collagen, morphology similar to human skin and high resistance and tensile extension at the break. We chose Baladi rabbits for their relatively ease of handling, accommodation and resistance to surgical aggressions and infectious processes, with low mortality. However, the choice of male rabbits is due to variations in hormonal cycles in females that could intervene in the process of tissue repair.
This experimental model was established to evaluate healing process and outcome results after application of Tilapia Fish Skin on acute contact thermal that was done in order to obtain injuries with the same size and depth.
- Conditions
- Tilapia Fish Skin in Burn Coverage
- Being tested
- TFS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TFSProcedure or surgery
burn coverage with TFS
| Study group | Role | What they receive |
|---|---|---|
| TFS | thermal burn coverage with Tilapia fish skin Receives: Procedure: TFS | |
| regular dressing | thermal burn coverage with regular dressing Receives: Procedure: TFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilapia Fish Skin Coverage in Acute Thermal Burn
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Sep 2022
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tilapia Fish Skin in Burn CoverageStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Anter, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549569
- Sponsor's protocol ID
- 696/11/22
- Acronym
- TFS
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tilapia Fish Skin Coverage in Acute Thermal Burn; Experimental and Histopathological Study
- ClinicalTrials.gov ID
- NCT06549569
- Acronym / sponsor ID
- TFS / 696/11/22
- Conditions
- Tilapia Fish Skin in Burn Coverage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 12 Aug 2024 (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.
The goal of this experimental study is to compare TFS and regular dressings as coverage for acute thermal burns. The main question it aims to answer is:
Is TFS effective in treating thermal burns? burn induction was done on rabbits to obtain second-degree thermal burn, followed by coverage with TFS
Detailed description
Nile Tilapia Fish Skin (NTFS) has been suggested as an option for biological material for the management of burns. Nile Tilapia Fish Skin also presented a large composition of type I collagen, morphology similar to human skin and high resistance and tensile extension at the break. We chose Baladi rabbits for their relatively ease of handling, accommodation and resistance to surgical aggressions and infectious processes, with low mortality. However, the choice of male rabbits is due to variations in hormonal cycles in females that could intervene in the process of tissue repair.
This experimental model was established to evaluate healing process and outcome results after application of Tilapia Fish Skin on acute contact thermal that was done in order to obtain injuries with the same size and depth.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TFS | – | Procedure: TFSthermal burn coverage with Tilapia fish skin |
| regular dressing | – | Procedure: TFSthermal burn coverage with regular dressing |
Who may qualify
- Ages
- 1 year to 18 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- animal rabbits
Key inclusion criteria (1 listed)
- healthy male one year old rabbit
Key exclusion criteria (1 listed)
- female unhealthy rabbits
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 |
|---|---|---|
| TFSburn coverage with TFS | Procedure or surgery | TFS, regular dressing |
Primary outcome
Tilapia Fish Skin Coverage in Acute Thermal Burn
Time frame: 1 year
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 12 Aug 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tilapia Fish Skin in Burn Coverage, run by Aswan 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 1 inclusion and 1 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 12 Aug 2024. 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?
Tilapia Fish Skin Coverage in Acute Thermal Burn (time frame: 1 year). 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 12 Aug 2024.